Careers

Join Our Team.

There has never been a more exciting time at Rani Therapeutics. We have successfully tested the RaniPill in humans, and we are working towards the ultimate goal of making the oral delivery of biologics a reality for millions of patients. We are growing rapidly and we are actively hiring.

Current Openings.

We are actively hiring and building our team. Check out some of our current open positions. If you think you have the right experience, and would like to be part of a dynamic team, we want to hear from you.

RELIABILITY ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking a Reliability Engineer to perform hazard evaluation, failure analysis and develop risk mitigation strategies in a regulated, biotech environment.  The position will work closely with R&D, manufacturing, process, packaging and quality to provide guidance on the reliability of new product designs that will ensure sustained robustness.  The position will also lead the effort to design relevant experiments, collect/analyze data and make sound recommendations to achieve high reliability as the company grows and scales up.    

Requirements
  • Actively participate in engineering design reviews and define appropriate metrics to measure/evaluate product reliability
  • Develop/conduct Design of Experiments (DOE) and reliability studies that would lead to  understanding of multiple variables that may affect product performance    
  • Define/establish test methods and statistical process control procedures to achieve desired product reliability
  • Propose/recommend appropriate materials, components and engineering concepts that minimize or eliminate the risk of failure 
  • Determine statistical sample size required for technical reliability studies 
  • Evaluate the current manufacturing hardware/software/process and make recommendations for achieving high reliability as the company scales and gears up for increased production throughput 
  • Work with internal engineering team as well as outside service providers to qualify new components, equipment and  processes from reliability standpoint
  • Using statistical software tools such as Minitab, perform data analysis, prepare relevant presentations/documentations/reports, highlight reliability issues and make appropriate recommendations 
  • Create appropriate infrastructure and set high standards for achieving/maintaining quality and reliability      
  • Review design changes for their impact on Quality and Reliability 
  • Participate and actively contribute to continuous improvement efforts that will streamline and improve the reliability process
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

  • BS degree in physics or mechanical Engineering or related technical field
  • 5-7 years of relevant engineering reliability experience in complex medical technologies
  • Must be hands-on and  be able to independently develop and perform experiments 
  • Extensive experience with mechanical/environmental stress, shock, drop, vibration and accelerated testing
  • Proven track record in a regulated environment , ISO, cGMP and QMS standards
  • Proficient with applying DOE, statistical analysis tools such as Minitab, dFMEA, pFMEA and other techniques to identify failure modes at system, sub-system and component level
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills 
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • MS or PhD in physics, engineering or equivalent
  • Knowledge/experience with polymers and processes such as injection molding and pressure forming
  • Familiarity with sterilization process

Travel

Up to 10%

Apply Now

SENIOR MECHANICAL ENGINEER

San Jose, California, United States - Full-time

Job Summary

We are seeking an exceptional Senior Mechanical Engineer to design, develop and validate semi or fully automated equipment that are used for the scale-up of high volume, disposable devices.  Your role is to find creative and sound engineering solutions to challenging problems with strong focus on quality, reliability and execution.  This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities and Sustaining.

Responsibilities

  • Develop concepts and ideas for improving exiting tooling as well as creating new tooling including semi-automation where applicable
  • Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators
  • Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch and documentation
  • Create 3D models, engineering drawings and bills of materials
  • Create comprehensive work instructions and manufacturing SOP’s
  • Create verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reports
  • Participate in design FMEA and plan steps for mitigating risks
  • Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

  • Bachelor’s Degree in Mechanical Engineering
  • 5-7 years hands-on, relevant experience
  • In-depth experience with complex mechanical/electromechanical design
  • Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
  • Experience with creating engineering drawings, BOMs and product specifications
  • Deep knowledge of material properties, heat treatment and surface finish
  • Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP and QMS standards
  • Good understanding of DFM and lean manufacturing
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills
  • Knowledge and/or hands-on experience with machine shop tools
  • Deep knowledge of GD&T as well as proficiency with SolidWorks
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • Master’s degree in Mechanical Engineering or equivalent
  • Knowledge/experience with plastic injection molding
  • Knowledge/experience with DOE, SPC, JMP /Minitab
  • Experience with metal stamping, laser cutting and chemical etching
  • Familiarity with and sterilization process and aseptic environment
  • PLC programming

Travel

Up to 10%

Apply Now

ASSEMBLER

San Jose, California, United States - Full-time
Description

Primary job function is to assemble parts and components used in the manufacture of medical devices. 

Requirements
  • Perform assembly operations requiring fine hand dexterity.
  • Understand and comply with Good Manufacturing Practices and Good Documentation Practices.
  • Comply with work schedules and properly report hours worked.
  • Have the ability to initial and date and write notes and other entries legibly.
  • Comply with all written procedures and safety practices.
  • Read and understand procedures written in English.
  • Assist in writing and updating assembly procedures, protocols and checklists. 
  • Evaluate problems and make initial recommendations for possible corrective actions for issues encountered on the line.
  • Work with production management and Quality Assurance to provide feedback regarding assembly procedures. 
  • Assure product and process quality by following Quality System procedures.
  • Maintain product and company reputation by complying with government regulations.

Education, Training, Skills and Experience Requirements: 

  • High School Diploma or equivalent 
  • 2+ years of experience in Medical Device or Pharmaceutical company
  • Must have good English written and verbal communication skills
  • Good arithmetic skills are required
  • Mechanical aptitude desired 
  • Medical device experience is preferred 
  • General proficiency of Microsoft Excel and Microsoft Word     
  • Contributes to team effort by accomplishing related results as needed.
  • Flexible demeanor and comfortable dealing with uncertainties 

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  

  • While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time.
  • Physical on site presence is required
Apply Now

SENIOR MANUFACTURING SUSTAINING ENGINEER

San Jose, California, United States - Full-time
Description

Supports the manufacturing of Rani Capsules. Works with engineering and quality to ensure device specifications conform to device requirements. Responsible for supporting the production lines with daily activities, process improvements, cost savings projects, customer/vendor changes, and consistency of assembly processes.

Requirements
  • Evaluate the current manufacturing processes /workflows to identify opportunities for improving 
  • Improve manufacturing efficiency, production yields, product quality, and consistency through equipment and product design, modifications, and fabrication.
  • Modify and improve existing equipment.
  • Complete projects, report status, and document lessons learned in an efficient manner.
  • Finalize manufacturing methods for medical devices.
  • Provide assistance for equipment design or producing medical devices and components.
  • Support production and manufacturing.
  • Engineering support which includes vendor contact and auditing specification.
  • Responsible for implementing tooling maintenance and upgrades.
  • Responsible for manufacturing methods and their transfer into production.
  • Follow SOP on re-validation of existing equipment, tooling and processes.
  • Develop improved processes, sampling activities, as well as tooling and manufacturing concepts that will meet customer expectations on cost, quality and delivery.
  • Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery of goals.
  • Lead process improvement and waste elimination efforts through application of lean principles and actively participate in continuous improvement events.
  • Work with Quality Control team to generate, update and implement all project related requests, process guides, and troubleshooting guides.
  • Performs Root Cause Analysis and Addresses CAPA on Manufacturing Non Conformances
  • Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)

Qualifications

  • BS in Mechanical Engineering, Manufacturing Engineering, or similar related field
  • 7+ years of engineering experience in manufacturing preferred
  • MiniTab (or other statistical analysis software), SolidWorks or CAD modeling software.
  • Experience in new product development, introduction processes and procurement protocols
  • Must be detail oriented, focused and able to produce accurate and professional documents
  • Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. 
Apply Now

MANUFACTURING PROCESS ENGINEER

San Jose, California, United States - Full-time
Description

Supports the manufacturing of Rani Capsules. Works with engineering and clinical to ensure device specifications conform to device requirements. Responsible for establishing baseline by evaluating the current manufacturing processes and making improvements to increase productivity, quality /reliability, and reduce cost and scrap

Requirements
  • Evaluate the current manufacturing processes /workflows to identify opportunities for improving productivity and quality while reducing cost /labor 
  • Perform process capability studies via DOE’s. Utilize statistical data analysis to arrive at sound conclusions and follow up with action plan for process improvements 
  • Develop standards and monitoring techniques to reduce variability in manufacturing that may include operator, material, equipment and processes 
  • Actively participate in discussions with appropriate functions and contribute to new initiatives that may include design, manufacturing, process /quality improvement as well as cost reduction
  • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
  • Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
  • Works with Development Engineers to effectively transfer new products to Manufacturing 
  • Complete design and development projects by training and guiding technicians and assemblers
  • Create verification /validation protocols (IQ,OQ,PQ), lead the execution activities, generate relevant data and provide corresponding documentation and reports
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 

Qualifications

  • Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related engineering fields
  • 3-7 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
  • Excellent verbal, written, presentation and interpersonal skills
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. 
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
  • Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC and process development/validation
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines  /processes
  • Knowledge of material science and polymer chemistry
  • Diverse background in process characterization and optimization in a manufacturing environment. 
  • Hands-on proactive approach to problem solving
  • Requires interaction and collaboration with a cross-functional team

Preferred Qualifications

  • Experience with Statistical Software tools such as Minitab or JMP 
  • Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
  • Familiarity with cleaning and sterilization processes 
  • Working knowledge of Solidworks 

Travel

  • Up to 10%
Apply Now

PROCESS ENGINEERING MANAGER

San Jose, California, United States - Full-time
Description

The Manager of Process Engineering is responsible for providing technical leadership and direction to a team of talented engineers. The successful candidate will have extensive experience in the areas of process development/optimization, continuous improvement, and cost reduction as well as verification & validation activities in a fast-paced environment. 

This is a hands-on position that requires interaction and collaboration with cross-functional teams including R&D Engineering, Automation Engineering, Manufacturing, Material, Quality, and safety. 

Requirements
  •   Develop standards and key performance metrics to reduce variability as well as improving quality, throughput, and efficiency 
  • Actively participate in early design concept reviews with R&D and Automation Engineering and provide objective feedback to ensure manufacturing robustness
  • Perform equipment characterization and define process windows by creating appropriate DOE’s and utilizing statistical data analysis
  • Own the verification/validation activities including generation of IQ/OQ/PQ protocols, execution and final reports as well as creating SOP’s, MPI’s LHR’s and providing appropriate training
  • Recommend production layouts for automation equipment and material flow for maximum efficiency
  • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
  • Provide support for existing equipment and ensure proper documentation and training
  • Lead new product transfer and manufacturing scale-up activities utilizing best manufacturing techniques
  • Champion and foster a mindset of quality and continuous improvement 
  • Adhere to project timelines, identify risks/issues, and recommend mitigations
  • Attract/hire top talent and ensure retention by providing coaching/mentoring and encouraging career growth 
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

  • Bachelor’s Degree in Chemical, Mechanical, Manufacturing, or related engineering fields
  • 5-7 years hands-on experience in the medical device field with proven track record of process development/optimization and validation
  • Minimum 3 years of proven leadership and people management
  • Excellent verbal, written, presentation and interpersonal skills
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards
  • Strong analytical and problem-solving skills including but not limited to DOE and statistical data analysis
  • Extensive experience with process capability studies, FMEA, GR&R, SPC and process development/validation
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes
  • Knowledge of material science and polymer chemistry
  • Experience with Statistical Software tools such as Minitab or JMP
  • Experience with Lean manufacturing 

Preferred Qualifications

  • Advanced engineering degree
  • Familiarity with aseptic manufacturing
  • Project management experience 
  • Knowledge and experience in plastics assembly techniques

Travel

  • Up to 10%
Apply Now

MANAGER/SR. MANAGER CMC ANALYTICAL DEVELOPMENT

San Jose, California, United States - Full-time
Description

Rani Therapeutics has developed a disruptive technology, RaniPillTM capsule that facilitates the oral delivery of biologics. Working at Rani Therapeutics involves taking a multi-disciplinary approach based on traditional device technologies such as mechanical engineering and material science in combination with pharma-centric disciplines such as physiology, pharmacology, chemistry and protein therapeutics. This unique environment allows Rani Therapeutics to address the most complex, unsolved problem of oral biologics delivery. The candidate in this position will play a pivotal role in our R&D Department working on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes.

Requirements
  • Comprehensive knowledge of state-of-the-art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc., for product characterization, comparability testing and PK/PD analyses.
  • Hands on experience in stage appropriate method validation and specification setting.
  • Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes.
  • Proven expertise in establishing and managing reference standard and stability programs.
  • Experience in protein purification and biologic formulation is a plus.
  • Participate in method and tech transfer from R&D to Manufacturing as appropriate.
  • Experience in writing, reviewing and approving CMC sections of regulatory filings.
  • Good working knowledge of GMP requirements, including ICH, FDA, and EMA guidelines, for development and manufacturing of drug products and/or drug-device combination products (a plus).
  • Assessing utilization of resources and identifying when, and where additional resources may be needed.
  • Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
  • A track record in collaboration with cross functions, including (but not limited to) Process/Engineering Development, Formulation/Drug Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs, is required.
  • To communicate effectively to the project team and present data at team meetings.
  • To maintain high quality documentation of all activities in notebooks, reports as required.
  • Keep up to date with relevant scientific and technical developments.

Education and/or Job Experience

  • B.S./M.S. or advanced degree (preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related fields.
  • Must have 5+ years of relevant pharmaceutical or biotechnology development experience.
  • Position and compensation will be commensurate with experience.

Skills and Specifications

  • A track record in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must.
  • Working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities.
  • Experience of working in GLP/GMP regulated environment.
  • Experience in working with drug-device combination products is a plus.
  • Excellent oral and written communication skills.
  • The ability to work as a member of a multidisciplinary team.
 
Apply Now

SENIOR AUTOMATION ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking an exceptional Senior Automation Engineer to design, develop and validate controller system hardware and software for semi or fully automated equipment that are used for the scale-up of high volume, disposable devices. You will be analyzing system requirements, creating electrical and pneumatic schematics as well as panel layouts, implementing custom programmable logic code, testing system functionality and efficiency, proving system safety, and providing operational support.

Requirements
  • Working closely with R&D, Manufacturing, and Process Engineering groups to develop concepts and ideas for automation where applicable
  • Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch and documentation
  • Develop engineering designs, including electrical schematics, panel layouts, and bill of materials for equipment. Knowledge of SolidWorks Electrical is a plus
  • Hands on PLC Controls system design, development, programming, and validation
  • HMI/GUI design and implementation. Apply human factors and usability engineering in the development and modification of software interfaces
  • Enable remote management of PLCs, controllers, and HMIs, as well as data logging 
  • Work with sustaining and maintenance to understand the root cause of control-related failures.
  • Provide engineering support, technical guidance, and training to operators
  • Able to work on multiple projects simultaneously in a fast-paced, energetic environment and manage competing priorities. Strong planning and organizational skills
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

  • Bachelor’s degree in software engineering, mechanical engineering, electrical engineering, or a related field
  • 5-7 years of hands-on, relevant experience

Qualifications

  • Proficiency expected in one of the following: Allen-Bradley (RSLogix 5000), Siemens, Omron, and or other industry standard PLC platforms
  • Working knowledge of Relay Ladder Logic (RLL). Understanding of Structured Text (ST), Functional Block Diagram (FBD), and Sequential Function Charts (SFC)
  • Experience in writing HMI user interface using FactoryTalk View and other industry standard Graphic User Interfaces
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Ability to troubleshoot equipment problems and perform complex system tests
  • Ability to work with minimal supervision

Preferred Qualifications

  • Advanced engineering degree
  • VFD programming and motor control. Working knowledge with SMC motor driver preferred
  • Experience with robotics (Epson, Denso, Omron), and machine vision
  • PLC technical certification
Apply Now

SENIOR MECHANICAL DESIGNER

San Jose, California, United States - Full-time
Description

We are seeking a Mechanical designer to support a wide variety of engineering activities in a fast-paced environment.  This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Process and Quality.

Requirements
  • Create 3D models and detail drawings by reverse engineering existing tooling and fixtures
  • Work closely with the Engineering and Manufacturing teams to understand design intent and incorporate Geometric Dimensioning and Tolerancing (GD&T)
  • Design new jigs and fixtures for Manufacturing
  • Perform tests and experiments when necessary to collect functional data as it relates to the current tools design  
  • Create complete documentation package including Drawings, BOM’s, work instructions, MPI’s, etc. and release on ECO
  • Provide design and documentation support to R&D and Manufacturing Engineering teams 
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 

Qualifications

  • Minimum 3 years of hands-on experience in a manufacturing environment 
  • Good understanding of mechanical/electromechanical design
  • Experience with mechanisms, pneumatics, fixtures/tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
  • Experience with creating engineering drawings and BOM’s 
  • Excellent verbal, written, presentation and interpersonal skills
  • Good understanding of GD&T as well as proficiency with SolidWorks
  • Familiarity with metrology tools
  • Associate degree in a technical field

Preferred Qualifications

  • Knowledge and/or hands-on experience with machine shop tools
  • Knowledge/experience with electrical /electronics 
  • Knowledge/experience with plastic injection molding
  • Experience with Micro-Vu 
  • Prior experience with FDA regulations, ISO, cGMP and QMS standards
  • Understanding of DFM and lean manufacturing

Travel

Up to 10%

Apply Now

SENIOR ELECTRICAL ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking an exceptional, highly motivated, and hands-on Senior Electrical Engineer to design, develop and validate novel circuits for medical devices and other non-conventional application circuits. Your role is to find creative and sound engineering solutions to challenging problems with strong focus on quality, reliability, and execution. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, and Biology.

Requirements
  • Collaborate with cross-functional teams to shape future technology integration into our products and define electrical specifications and requirements.
  • Hardware engineering duties include component analysis, circuit design, schematic capture, component placement, PCB routing, prototype bring-up and general debugging.
  • Analog and mixed-signal design and simulation (discrete transistors, op-amps, filters, advanced sensors integration)
  • Digital design (microcontroller, memory, digital interfaces such as I2C/SPI, UART, USB)
  • Wireless protocol integration (Bluetooth and Wi-Fi)
  • Electrical functional verification and signal characterization of all designs. 
  • Develop test plans and systems to test designs in lab and manufacturing environments.
  • Model, analysis, and documentation of risks and mitigation strategies, optimizations for efficiency, manufacturability, testability, and overall user experience.
  • Firmware engineering duties may include overall architecture, power management optimization, code implementation, testing and maintenance. 

Education and/or Job Experience

  • Bachelor’s degree in electrical engineering or a related field
  • 5-7 years of hands-on, relevant experience

Qualifications

  • Must demonstrate strong EE and firmware fundamentals.
  • Must have hands-on experience in prototype bring-up and debugging, functional verification, and manufacturing support. Ability to solder and rework is a plus.
  • Broad experience in low power embedded system design, including architecture development, component selection, schematic capture, PCB layout, and prototype development. Working experience with Altium Designer is a plus.
  • Deep understanding of wireless communication software and firmware architectures. Experience with Bluetooth LE is preferred.
  • Must demonstrate strong verbal and written communication skills.
  • Strong analytical and problem-solving skills.
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks.

Preferred Qualifications

  • Master’s degree in Electrical Engineering or equivalent
  • Knowledge/experience with ultralow power design
  • Knowledge/experience with RTOS with BLE stack
Apply Now

QUALITY INSPECTOR

San Jose, California, United States - Full-time
Description

The Quality Inspector is responsible for supporting all receiving inspection activities, including all aspects of inspection (receiving, first article inspection and in-process). Perform visual and dimensional inspections as defined by our Standard Operating Procedures and Engineering Drawings. This position will be required to determine accept / reject disposition based on inspection results. As the Quality Inspector, you will support the Development and Production/Manufacturing departments with inspections of materials/parts/products, while maintaining compliance with Quality Management System (QMS) procedures. 

Requirements
  • Perform inspection of parts/materials received, in-process, and finished products for conformance to specifications and in accordance to QMS procedures 
  • Perform inspection using a variety of standard metrology equipment, including: Micro-Vu, height gauge, pin gauges, calipers, micrometers, surface table, gauge blocks, dial indicators, durometer, etc.
  • Read engineering drawings and interpret geometric dimensioning and tolerance, be able to perform inspection with minimal supervision
  • Determine inspection sample size based on procedures, specifications, and standards. 
  • Perform analysis per the established procedures/specifications to make pass/fail decisions
  • Document inspection activities in accordance to quality procedures and Good Documentation Practices
  • Maintain accurate records as per Document Control procedures
  • Report discrepancies and issues to QA Lead and affected function(s)
  • Initiate NCMRs when failed results are obtained or discrepancies are observed during the inspection process
  • Assign and apply expiration dating labels to materials/parts, as per the specifications/quality procedures
  • Interact closely with different functions of the organization
  • Assist in the development of inspection methods to support products under development
  • Performs other duties as needed to support the Quality Assurance Department and the company

Education and/or Job Experience

  • Minimum of 3 years of experience performing inspections
  • Micro Vu or similar CMM experience is required
  • Experience with AQL Sampling using C=0 Sampling Plan
  • Knowledge and use of precision testing equipment and tools
  • Government Regulated Environment experience such as FDA and ISO
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel)
  • Experience working in a cGMP environment

Skills and Specifications

  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
Apply Now

EQUIPMENT ENGINEER

San Jose, California, United States - Full-time
Description

The Equipment Engineer is responsible for planning, coordinating and directing the operations of all equipment for effective calibration, maintenance and repair programs. This position organizes the arrangements for technical evaluation of equipment, purchase orders, planning, and scheduling of all calibration and preventive maintenance activities internally and by outside approved suppliers. Reviews and tracks the records, inspections, calibrations, and service agreements for the organization’s equipment and tools. The position acts as a technical advisor on all equipment issues and technical feedback to the management team with equipment including but not limited to use, budgets, and potential equipment purchases. This position works closely with all Rani departments to ensure adherence to the Rani Equipment Calibration and PM procedures. 

Requirements
  • Update calibration and PM procedures and forms within the Quality Management System as needed
  • Review all equipment specification information for completeness and appropriateness for the usage of the equipment 
  • Qualify equipment to ensure the fulfillment of all requirements including IQ/OQ validation and verification activities. Ability to create and execute quality documentation for internally and externally designed production equipment 
  • Determine troubleshooting, maintenance, and calibration procedures for each piece of equipment and train relevant personnel to perform them.  Participate in troubleshooting and repair of test equipment as required
  • Thoroughly document all aspects of the equipment, including its requirements, design, operation, and qualification in compliance with Good Manufacturing Processes (GMP).
  • Initiate equipment specifications for calibration information by collaborating with equipment owners, such as calibration parameters, tolerances and intervals
  • Developing detailed reports or instructions to show how to calibrate/PM a new machine
  • Review equipment specifications for the appropriateness of all preventive maintenance requirements
  • Manage and maintain equipment database and equipment files 
  • Ensure appropriate labels are affixed to the equipment and tools, such a “No Calibration or PM Required”
  • Collect, report, and monitor calibration/PM performance metrics monthly and report to the QA management
  • Ensures scheduling of outside sources in accordance with established calibration frequencies and initiating supplier approval process if needed
  • Coordinates with equipment owners and departments to issue and control all scheduled equipment due for calibration and PM and ensure to communicate the risks of possible scheduling challenges
  • Ensures and verifies that any calibration/PM service providers are approved suppliers per Rani procedures
  • Monitor CAL/PM schedule to ensure necessary equipment is properly calibrated/PM’ed in a timely manner
  • Review all calibration and preventive maintenance records and certificates for accuracy and completeness, as per internal procedures.
  • Initiate an NCMR and report any out of tolerance (OOT) results, represent QA on investigation and NCMR closure
  • Responsible to secure inactive equipment/tools in designated storage area and archiving the corresponding files
  • Any projects or tasks assigned by management

Education and/or Job Experience

  • BS in engineering degree and/or related certifications
  • A minimum of three years of equipment management experience with a working knowledge of equipment qualification, calibration and PM procedures and practices. 
  • Three years of related experience in an FDA regulated industry is preferred
  • Must have knowledge of metrology skills including a sound understanding of dimensional tolerances and usage of precise mechanical measurement instruments
  • Must demonstrate ability to be accurate and identify procedural inaccuracies and make recommendations for ongoing improvements and effectively implement changes
  • Must demonstrate ability to work independently, make effective decisions, and resolve technical issues
  • Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization across all departments and proactively identify issues and recommendations improvements
  • Must demonstrate the ability to work effectively in teams to achieve results
  • Basic proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is preferred

Skills and Specifications

  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges
  • Flexible and adaptable to changing environment and priorities 
Apply Now

MECHANICAL DESIGN LEAD

San Antonio, Texas, United States - Full-Time
Description

We are seeking an innovative Mechanical Design Lead to oversee and support the development of a novel drug delivery system in a fast-paced environment. As the technical lead, you will direct a technical team and will be responsible for evaluating and improving the drug delivery system under development while maintaining high quality and reliability standards. This is a hands-on position that requires interaction and collaboration with cross-functional teams.

Requirements
  • Determine project requirements and developing work schedules for the team
  • Delegate tasks and achieve weekly, monthly, and quarterly milestones and goals
  • Work closely with the engineering team to understand design intent, evaluate design, and identify opportunities to realize improvement in performance
  • Design, create and review 3D models, detailed drawings, and bill of materials
  • Show proof of concept through prototype and supporting test data, and coordinate implementation with appropriate stakeholders
  • Perform and oversee tests and experiments when necessary to collect functional data.
  • Identify risks and forming contingency plans as soon as possible
  • Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
  • Generate progress reports and deliver presentations to management and other stakeholders on a regular basis
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

  • Bachelor’s degree in mechanical engineering, biomedical engineering, or a related field
  • 5-7 years of hands-on, relevant experience in a design environment
  • Relevant management certification may be required

Qualifications

  • Experience with creating engineering drawings, BOMS, and product specifications
  • Proficiency with SolidWorks required
  • In-depth experience with complex mechanical systems that interact with biology
  • Prior experience in a medical device company
  • Experience with design control process for medical devices and implementation of product into manufacturing
  • Working knowledge of FDA regulations and ISO, cGMP, QMS standards.
  • Good understanding of DFM and lean manufacturing
  • Knowledge/experience with plastic injection molding
  • Knowledge and/or hands-on experience with machine shop tools
  • Must demonstrate strong verbal and written communication skills
  • Strong analytical and problem-solving skills
  • Creative, self-motivated, and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • Master’s degree in mechanical engineering, biomedical, engineering, or equivalent
  • Knowledge/experience with injection molding bioabsorbable materials is a plus
Apply Now

CORPORATE COMMUNICATIONS MANAGER

San Jose, California, United States - Full-time
Description

Rani is currently seeking a Communications Manager to support public relations, social media, investor relations and employee communications activities. This person will be responsible for developing and implementing communications campaigns that align with our business objectives and help engage our key stakeholders. The Corporate Communications Manager will manage the PR program, including interacting with and advising the PR agency and working with Rani’s executive team on these initiatives. This person will also be responsible for supporting communications efforts for media relations, investor relations and employee communications. The role will include preparation of various communications materials including presentations, press releases, reports, investor summaries. This role will report to the VP of Business Development and is based in San Jose, CA. 

Requirements
  • Deep knowledge and experience in public relations and a proven ability to execute results-oriented PR campaigns 
  • Interest and track record in using social media for corporate communications efforts 
  • Excellent written and verbal communications skills, including experience in writing and editing communications materials for media, investors, employees 
  • An aptitude for/interest in research to understand industry trends, competitive landscape, and market developments that relate and inform communications initiatives 
  • Self-starter with track record for managing multiple projects with clear attention to detail
  • Strong organizational skills
  • Team player with excellent interpersonal skills
  • Comfort and confidence working with leaders and other team members 
  • Strong analytical and problem-solving skills 
  • Creative, self-motivated, and flexible 
  • Experience managing investor communications is a plus

Qualifications 

  • A bachelor’s degree is required 
  • Minimum of 8 years communications experience in the life sciences industry, such as medical device or pharma (either working for a company or life sciences-focused agency) 
 
Apply Now

BUSINESS DEVELOPMENT MANAGER

San Jose, California, United States - Full-time
Description

Rani is currently seeking a Business Development Manager to support all aspects of business development initiatives. This person will be responsible for business development research and scouting to assess market developments and identify potential partnering opportunities. This person will also support business development transactions including due diligence and onboarding for R&D collaborations and licensing. This role will report to the VP of Business Development and is based in San Jose, CA. 

Requirements
  •  Lead research and analysis of pharma landscape to identify strategic partner opportunities 
  • Evaluate and present opportunities internally to support internal pipeline and strategic priorities 
  • Identify, analyze, and prioritize relevant external innovation opportunities including from industry and academia
  • Conduct market research and competitive analysis to identify market trends and developments
  • Regularly review and summarize literature and competitive intelligence for leadership team
  • Create financial models to support BD decision-making and analysis of opportunities 
  • Develop and cultivate relationships within the biotech community, attending conferences and trade shows as needed
  • Support due diligence efforts including materials development, coordination, data room management and maintenance 
  • Excellent organizational, communication and interpersonal skills 
  • Strong analytical and problem-solving skills 
  • Self-starter with track record for managing multiple projects

Qualifications 

  • A bachelor’s degree is required 
  • MBA or Master’s a plus
  • Minimum of 5 years of Business Development experience such as search and evaluation for pharma (preferable), medical device or biotech venture capital 
  • Background and experience in financial modeling 

Travel

  • Some travel required to support scouting at conferences, partner meetings 
Apply Now

RESEARCH SCIENTIST

San Jose, California, United States - Full-time
Description

This is an exciting opportunity for a bioanalytical scientist to join our staff at our San Jose facility and work on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically change patient outcomes.   Position, salary and benefits are commensurate with experience.  All full time salaried employees are offered an attractive compensation package which includes medical insurance benefits, relocation, 401K, and paid vacation. In addition, all full time salaried employees receive option grants. 

The ideal candidate is expected to play a pivotal role in our R & D team. The candidate must have a background in medical device or pharmaceutical testing and regulatory development. Experience in preclinical and clinical research is a must. The candidate must have a background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. Experience with microplate assays is must and experience with Luminex MapX technology is an advantage.

Requirements
  • Perform bioanalytical assays for the quantification of the analytes in in vitro, preclinical and clinical samples. 
  • Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision. 
  • Configure, program and troubleshoot laboratory automated platforms.
  • Optimize existing automated processes to improve efficiency, throughput, robustness and quality.
  • Understands the principles, concepts and methodology governing the work performed 
  • Fully understands the rationale and hypotheses for experimental designs 
  • Demonstrates solid technical skills and working familiarity with laboratory procedures and processes 
  • Reads and understands scientific literature directly related to his/her experiments, as assigned 
  • Performs literature searches independently and begins to interpret results 
  • Begins to acquire an understanding of the scientific implications of scientific literature for his/her projects/functions 
  • Performs routine data management tasks including recording results effectively in a laboratory notebook or computer independently (i.e., tabulating and graphing results) 
  • Support regulatory efforts through understanding of relevant standards and interpretation of FDA Guidance documents.
  • Actively participate in company-wide research meetings, including making detailed scientific presentations. 
  • Work cooperatively with scientists, personnel in other departments. 
  • Other duties as assigned.

Teamwork 

  • Participates effectively as a member of a team within his/her laboratory/project 
  • Proactively seeks assistance, when necessary, from other scientists to solve problems with procedural protocols 
  • Promotes exchange of ideas and information

Laboratory Management Responsibilities 

  • Maintains cleanliness in his/her own work area and in communal work areas 
  • Responsibly ensures adequate maintenance of laboratory supplies and equipment

Safety 

  • Responsible for his/her own safety in the laboratory, and alertness for the safety of co-workers and visitors 
  • Learns safety requirements for his/her laboratory. Attends safety training, as appropriately needed 

Education and/or Job Experience

  • Minimum work experience: a Bachelor’s degree with 2-5 years of work experience or a Master’s degree plus 0-3 years of work experience (academia- or industry-based) or a Ph. D. with at least 2 years of industry experience 
  • Executes experiments based on established protocols and implements improvements with limited supervision 
  • Hands-on experience in automation and liquid handling in a bioanalytical lab setting
  • Knowledge and experience of working with statistical software like Excel, GraphPad Prism and Softmax Pro.
  • Experience with writing reports/protocols and SOPs.
  • Excellent oral and written communication skills
Apply Now

PRODUCTION SUPERVISOR

San Jose, California, United States - Full-time
Description

The Production Supervisor will be responsible for daily management of Production operators. The Supervisor is responsible for training of all the operators, ensuring safety compliance, managing the weekly Production Schedule, reporting of equipment malfunctions to the Manufacturing Engineering, and maintaining GMP (Good Manufacturing Processes). The position responsible for maintaining Production compliance with applicable FDA and ISO requirements.

Requirements
  • Maintain a SAFE environment 
  • Monitor attendance, compliance, and good documentation practices
  • Familiarity with assembling small parts under microscope 
  • Manage vacation, sick time for employees and the impact it may have on the daily, weekly and monthly schedule.
  • Willing to step in and perform assembly as needed. 
  • Ability to work on flexible schedule and prompt arrival for shifts 

Qualifications

  • 5+ years’ experience in Medical Device or Pharmaceutical manufacturing company
  • 2+ years supervisory or lead experience preferred 
  • Education: Minimum High School, G.E.D. 
  • Experience working in Cleanroom environments (Class 10000)
  • Knowledge of 5S and Continuous Manufacturing Flow a plus
Apply Now

SR. QUALITY SUPPLIER ENGINEER

San Jose, California, United States - Full-time
Description

As a Senior Supplier Quality Engineer, you will be responsible for the management of suppliers, with accountability to support selection, approval and qualification of new suppliers or changes to existing supplied products and processes, as well as oversight of performance and improvement activities. This position will plan, coordinate and direct the supplier approval process.  Drive supplier-related investigations, corrective action implementation, and corrective action verification activities.

Requirements
  • Lead supplier qualification and requalification activities, including audits and supplier quality agreements
  • Develop and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
  • Plan, execute, report and follow-up on supplier quality system audits
  • Partner with Materials, R&D, Engineering, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions
  • Support internal and supplier root cause investigations and CAPA. Drive corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and preventive actions
  • Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes
  • Manages development of supplied product/component qualification plans, including supplier validations, control plans, inspection procedures, and first article requirements
  • Assess and process supplier changes
  • Assists in generating component specifications
  • Reviews new design specifications and provides input from component quality and manufacturability perspective
  • Reviews and approves supplied product drawings and component specifications
  • Perform component qualification/validations
  • Perform test method validations, and test equipment to assure the design and production of products are in compliance with applicable standards
  • Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution
  • Prepare Supplier Quality Agreements and drives discussion with supplier
  • Responsible for communicating business related issues or opportunities to next management level
  • Manage and maintain ASL database and supplier files
  • Any projects or tasks assigned by management

Education and/or Job Experience

  • Bachelor’s degree in Engineering or a related field
  • A minimum 4 years of supplier quality engineering experience in an FDA regulated industry
  • Thorough understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements
  • ISO 13485 Lead Auditor certified is a plus
  • Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls
  • Component Qualification/Process Validation experience 
  • Must demonstrate ability to be accurate and identify procedural inaccuracies and make recommendations for ongoing improvements and effectively implement changes
  • Must demonstrate ability to work independently, make effective decisions, and resolve technical issues
  • Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization

Skills and Specifications

  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team to achieve results
  • Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges
  • Flexible and adaptable to changing environment and priorities
Apply Now

PURCHASING ASSISTANT

San Jose, California, United States - Full-time
Description

Purchasing Assistant has the responsible to support the Senior / Buyer Planner in ensuring Purchasing Requests are properly executed. This position will also assisting in ensuring outsourced material availability to support the production schedule. The position will also aid in expediting Production Work Orders. 

Requirements
  • Place purchase orders with suppliers for the procurement of production material as required by forecast and the production schedule
  • Monitor status of open purchase orders to ensure on-time delivery of all materials, including timely resolution, communication and mitigation of future potential problems 
  • Manage and resolve issues regarding PO to invoice discrepancies, returns and quality problems with suppliers 
  • Coordinate Vendor Component Supply Deliveries. Ensure no shortages that would affect Production schedule. Expedite or defer orders as required based on schedule/inventory changes 
  • Ensure and promote compliance to Company and Procurement policies and procedures
  • Monitor Purchase Price in order to obtain reduce cost without sacrificing quality
  • Assist expediting Production Work Orders 
  • Coordinate with Accounting on Invoicing 
  • Ensure compliance to Rani Quality systems and QSR 

Education and/or Job Experience

  • High School Diploma
  • 2-5 years related work experience 

Skills and Specifications

  • Good interpersonal skills and organizational skills with attention to detail.
  • Ability to understand and follow written and verbal instructions, procedures and protocols.
  • Basic math skills, worth the ability to reason and solve problems.
  • Ability to work in a fast-paced, start-up manufacturing environment.
  • Team oriented with a positive attitude, creative, energetic, good work ethic, and willingness to learn.
  • ERP Experience a plus
Apply Now

SR. QUALITY ENGINEER - MEDICAL DEVICE

San Jose, California, United States - Full-time
Description

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Requirements
  • Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
  • Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
  • Provide QE support to production, purchasing and engineering
  • Support/lead test method validation activities
  • Conduct and support the development and validation of appropriate test methods for product and process performance
  • Develop and initiate sampling procedures and statistical process control methods
  • Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
  • Address systemic quality issues with suppliers or internal groups
  • Oversee calibration and preventive maintenance program
  • Assist in the review of lot history records and disposition of product (subassembly and finished goods)
  • Work with engineering to develop adequate inspection criteria
  • Perform statistical analysis such as capability, gage R&R, and statistical process control
  • Evaluate product changes for qualification and validation requirements and assist in change implementations
  • Other duties/ activities may be necessary to support departmental or company goals

Education and Job Experience

  • A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device,) is required
  • BS degree in Engineering is required
  • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience with non-conformances, CAPA, and Risk Management is required
  • Experience in performing test method validation and Gage R&Rs
  • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
  • CQE, CQA preferred

Skills and Specifications

  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
  • Ability to create and provide training
  • Good statistical and numerical ability
Apply Now

QUALITY ENGINEER - ASEPTIC MANUFACTURING

San Jose, California, United States - Full-time
Description

The Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an  effective quality management system and implementing continuous improvements. This is a hands-on role where the  Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and  combination products. This position requires technical expertise in Aseptic Techniques. The Quality Engineer is  responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance  with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture,  and distribution of products.  

Requirements
  • Maintain and improve Rani Quality System in accordance with FDA Regulations and ISO 13485 requirements
  • Provide hands-on direction for aseptic process and cGMP manufacturing activities
  • Support quality assurance activities, including, but not limited to: Risk Management (NCMRs and CAPAs
  • Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
  • Conduct investigations for issues associated with audits, lot history records and complaints. 
  • Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes 
  • Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes. 
  • Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
  • Assist in the review and approval of lot history records and test records 
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan 
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause 
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs 
  • Develop and initiate sampling procedures and statistical process control methods
  • Other duties/ activities may be necessary to support departmental or company goals 

EDUCATION AND/OR JOB EXPERIENCE 

  • Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline 
  • A minimum of 6 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
  • cGMP experience is required 2 of 2 
  • Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred
  • Excellent communication skills both oral and written
  • Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations 
  • Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) 

SKILLS AND SPECIFICATIONS

  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem[1]solving skills 
Apply Now

ELECTRICAL ENGINEER I

San Jose, California, United States - Full-time
Description

We are seeking an exceptional, highly motivated, and hands-on, entry level Electrical Engineer. You have the opportunity to design, develop, and validate novel circuits for medical devices and other non-conventional application circuits. Your role is to find creative and sound engineering solutions to challenging problems. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, and Biology. 

Requirements
  •  Hardware engineering duties include component analysis, circuit design, schematic capture, component placement, PCB routing, prototype bring-up and general debugging
  • Analog and mixed-signal design and simulation (discrete transistors, op-amps, filters, advanced sensors integration)
  • Digital design (microcontroller, memory, digital interfaces such as I2C/SPI, UART, USB)
  • Wireless protocol integration (Bluetooth and Wi-Fi)
  • Electrical functional verification and signal characterization of all designs. 
  • Develop test plans and systems to test designs in lab and manufacturing environments.
  • Model, analysis, and documentation of risks and mitigation strategies, optimizations for efficiency, manufacturability, testability, and overall user experience.
  • Firmware engineering duties may include overall architecture, power management optimization, code implementation, testing and maintenance. 

    Education and/or Job Experience

  • Bachelor’s or Master’s degree in electrical engineering or a related field
  • 1+ years of hands-on, relevant experience, show us your projects

    Qualifications

  • Must demonstrate strong, technical EE knowledge and firmware fundamentals.
  • Must have hands-on experience in prototype bring-up and debugging, functional verification.
  • Ability to solder and rework is a plus.
  • Working knowledge or experience with Altium Designer is a plus.
  • Must demonstrate strong verbal and written communication skills.
  • Strong analytical and problem-solving skills.
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks.

    Rani Management is an equal opportunity employer. This means that Rani Management is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law. Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies. 

Apply Now

DIRECTOR/SENIOR DIRECTOR OF R&D

San Jose, California, United States - Full-time
Description

We are seeking an exceptional Director of R&D to lead a technical team in a regulated environment.  The successful candidate will have hands-on experience throughout the development lifecycle from gathering requirements to design, execution, and validation of complex products.  The position has responsibility for strategic planning, adaptation and leading new technologies as well as improving/optimizing existing designs to ensure robust/sustainable products that meet stringent functional performance standards. These efforts are highly cross-functional requiring excellent interpersonal, communication and collaboration skills with colleagues in Manufacturing, Biology, Quality Assurance, Process Engineering, Automation Engineering and EH&S.   

This is an excellent opportunity for a strong leader to participate in the growth of a fast-paced, pioneering company. 

Requirements
  •  Oversee R&D activities from specifications, PoC, mechanical design, prototyping, test plans, V&V, technical reports, and design control compliance through clinical and commercial production
  • Establish metrics/KPI’s for monitoring device performance and implement appropriate mechanisms for continuous improvement
  • Anticipate financial needs and manage budget in accordance with forecast, schedules, and business needs
  • Communicate progress to stakeholders including the executive leadership team and provide recommendations for mitigating risks/delays 
  • Maintain strict compliance with ISO13485 and other applicable Quality Management System standards
  • Develop and implement policies, standards, procedures, and best practices for the engineering and technical work
  • Prioritize projects and resources based on business strategies
  • Hire/mentor new employees, enforce rules, resolve internal conflicts, and write annual performance reviews
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 

Education and/or Experience

  • Bachelor’s Degree in Mechanical Engineering, Material Science, or other engineering disciplines
  • 20+ years of hands-on industrial experience with product development in pharmaceutical, medical device, or life science industry 
  • Minimum 15 years of significant experience in leadership and people management
  • Advanced verbal and written communications skills with proven track record of team building, conflict resolution, and driving decisions 
  • Proven track record of strategic planning and influencing decisions to invest in new technology platforms
  • Knowledge and experience of financial budgeting to evaluate new technologies and make recommendations based on ROI, technical feasibility, and business needs
  • Knowledge and experience with polymers, injection molding, pressure forming and  ultrasonic welding  
  • Proven track record of hiring and developing top talent 
  • Effective critical thinking, negotiation and influencing skills 
  • Proven track record with Medical Device, FDA regulations, ISO, cGMP and QMS standards
  • Meeting deadlines is a must

Preferred Qualifications

  • Advanced degree in Business or Engineering 
  • Familiarity with sterilization process and aseptic manufacturing

Travel

  • 10%
Apply Now
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