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.

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

PATENT ATTORNEY

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

The Opportunity: In-House Patent Attorney (Full-Time)

Are you currently at least a 4th year patent associate in a mid-to-large-size law firm? Have you decided that you want a different path than partner track, or you wish to be able to do your best quality work outside the constraints of the billable hour? Do you like to continually learn and be challenged? If you are answering yes to these questions, read on for this opportunity that you might not want to miss.

The Company

Rani is a clinical-stage company and developer of the RaniPill™ robotic swallowable capsule. The market potential of the RaniPill™ capsule to replace injectable biologics with oral versions represents multiple billion-dollar opportunities for diabetes, arthritis, psoriasis, hemophilia and other conditions.

Requirements
 

The Position

Rani is looking for a patent attorney who can manage and contribute to its extensive and growing patent portfolio, which encompasses various technologies and corresponding relationships to anatomy, physiology, and pharmacology. The attorney will interact with engineers and scientists, prepare new patent applications, prosecute existing applications, and be a key contributor to the patent portfolio strategy. The position reports directly to the Vice President of Intellectual Property and is onsite in San Jose, California. There will be opportunities for growth and advancement. The person who will be successful in this position will be self-driven and proactive and able to self-reprioritize in response to changing circumstances.

Background Requirements

The candidate must have an engineering degree, be a licensed attorney, and be registered at the USPTO. The candidate should have experience with medical devices. The preferred candidate will have industry experience as an engineer or scientist, and/or have technical degrees in multiple disciplines. 

Compensation

Compensation and title will be competitive and commensurate with expertise and level of experience.  Compensation will include equity and a competitive benefits package. 

Apply Now

PROJECT MANAGER

San Jose, California, United States - Full-time

Job Description

We are seeking an experienced Project Manager to lead the successful execution and launch of engineering projects in a fast-paced environment.  The position has responsibility for daily management of complex projects and requires a high degree of coordination with a cross-functional team including Engineering, Manufacturing, Biology, Quality and Facilities.

Job Requirements

  • Oversee and drive multiple engineering projects of various size and complexity from initiation through validation and production release
  • Responsible for developing realistic project schedules, along with resource planning, risk management and measurable metrics to meet the project goals
  • Communicate progress to stakeholders including the executive leadership team and provide recommendations for mitigating risks or delays 
  • Coordinate interdependent tasks and deliverables with key stakeholders including R&D Engineering, Manufacturing & Process Engineering, Facilities, EH&S, and Quality Assurance
  • Lead and manage team meetings by creating agendas, presentations, minutes and action items. Document team decisions and follow up on action items and deliverables
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 
Qualifications
  • BS degree in engineering or a related technical field
  • 7-10 years of experience with managing engineering projects and use of standard project management methodology, tools and/or software packages
  • The successful candidate will apply strong people and negotiation skills to plan, coordinate and execute all relevant activities in a phase- gate setting 
  • Excellent interpersonal skills with an ability to communicate to people at all levels of the organization
  • Strong leadership skills, self-motivated and ability to influence others to achieve successful outcomes 
  • The position requires a high degree of adaptability, flexibility, creative decision-making, and technical problem-solving abilities 
  • Excellent verbal, written, presentation and interpersonal skills
  • Must be able to handle multiple projects with exceptional organizational and time management skills
  • Proven experience using Project Management tools to manage complex project timelines as well as fluency with Excel, Word, PowerPoint and Visio 
  • Proven track record with Medical Device, FDA regulations, ISO, cGMP and QMS standards
  • In-depth understanding of verification & validation (IQ,OQ,PQ) as well as risk analysis (FMEA)
Preferred Qualifications
  • PMP certification
  • Experience with Visual Project Management 
  • Experience with turnkey, capital equipment
  • Familiarity with sterilization process and aseptic manufacturing
Travel
Up to 10%
Apply Now

PRECLINICAL RESEARCH ASSOCIATE; SCIENTIST II-III

San Jose, California, United States - Full-time

Purpose of the job

The Preclinical Research Associate is responsible for assisting in all ongoing preclinical projects both in vitro and in vivo and will help gather data to evaluate and improve the current drug delivery system.  This person will be working with a multidisciplinary team of Scientists and Engineers to optimize the Rani platform.

Major Duties and Responsibilities

  • Participate in complex in vivo studies, working closely with the Preclinical team and outside CROs
  • Establish relationships with CROs for conduct of non-GLP as well as GLP studies
  • Requires traveling to offsite CROs for conducting studies. This includes driving up to 2 hours each way; out of state travel may be required.  Work may entail spending several days out of town to oversee studies at the CRO sites
  • Maintain laboratory equipment and supplies, ensuring proper calibration (if necessary) is conducted accordingly
  • Must have excellent organizational skills and be able to record and manage experimental data from various experimental studies ongoing concurrently
  • 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 a multidisciplinary team of Scientists, Engineers, and personnel in other varying departments
  • Contribute to hands-on in vitro laboratory work as needed, which may include isolated tissue experiments and ELISA/HPLC assays

Education and/or Job Experience

  • B.S., or M.S. in Animal Science, Animal Biology, or related field with at least 3 years of in vivo research experience
  • Experience in one or more therapeutic areas: Gastrointestinal (GI), Central Nervous System (CNS), Cardiovascular (CV) and metabolic diseases

Preferred Qualifications:

  • Research experience with large (non-rodent) animal models
  • Industry / Contract Research Organization (CRO) experience

Skills and Specifications

Competencies:

  • Proficiency in English with effective written and oral communication skills
  • Teamwork
  • Ability to work in a fast pace environment; learn and become familiar with techniques in both the engineering and biological sciences
  • Familiarity with basic lab techniques (ex. Pipetting)
  • Microsoft Office (Word, Excel, Powerpoint)
  • Experience with GraphPad Prism a plus
Apply Now

DIRECTOR OF REGULATORY AFFAIRS

San Jose, California, United States - Full-time

Purpose of the job

The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) and for covering multiple development projects.

Major Duties and Responsibilities

  • Develop and execute regulatory strategies for earliest possible approvals for development programs.
  • Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
  • Set strategy for submissions of product registration documents to health authorities worldwide. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions.
  • Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA and other submission documents including meeting packages, briefing documents, responses, supplements etc.
  • Experience in CMC regulatory compliance to ensure CMC practices are carried out in agreement with regulatory agencies requirements and expectations
  • Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites.
  • Interact with regulatory agencies on defined matters. Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
  • Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable.
  • Interface with international affiliates on regional regulatory strategy and implementation of plans.
  • Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.

Education and/or Job Experience

  • Bachelor’s or Master’s degree in a scientific discipline.
  • 10-15 years’ experience in Regulatory Affairs in biotechnology & pharmaceutical industry.
  • Thorough knowledge of the drug, device and combination product development process with demonstrated experience in developing global regulatory strategy and submissions.
  • Experience in multiple phases of development in various therapeutic areas is desirable.
  • Experience with biologics is a must.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Ability to communicate and interact effectively across departments and on project team(s).
  • Results driven and team-orientated, with the ability to influence outcomes.
  • Ability to travel
Apply Now

SR. QUALITY ENGINEER – cGMP

San Jose, California, United States - Full-time

Job 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 pharmaceutical and combination products.  This position requires technical expertise in Aseptic Techniques.  The Senior 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. 

Job 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 (FMEAs, HA), internal and external audits, 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. Approve manufacturing and testing deviations and investigations
  • 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. These duties will include, but are not limited to: the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
  • 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
  • Conduct audits at CMO, testing operations and internal audits
  • 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
  • Address systemic quality issues with suppliers or internal groups
  • 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

  • Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline
  • A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
  • cGMP experience is required
  • 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-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

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

RESEARCH SCIENTIST II

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 Research scientist plays a pivotal role in our R & D department on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes.  

Requirements
  • Designs and undertakes high quality scientific experimentation resulting in formulation and process development of parenteral dosage forms 
  • Designs novel device component subassemblies for a novel device pill that support immediate and sustained release of biologics
  • Assesses the chemical and physical stability of formulations in collaboration with analytical department
  • Identifies appropriate stability, manufacturability, and performance issues.
  • Oversees tech transfer from R&D to Manufacturing 
  • Interprets scientific data to derive clear conclusions and contribute to the direction for future work.
  • Communicates effectively to the project team and present data at team meetings.
  • Maintains high quality documentation of all activities in notebooks, reports as required.
  • Keeps up to date with relevant scientific and technical developments.

Education and/or Job Experience

  • Ph.D./M.S. in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields.
  • Must have 3+ years of pharmaceutical or biotechnology research experience.
  • Title will be commensurate with experience

Skills and Specifications

  • Experience in working with drug-device combination products is a plus
  • Experience of working in GLP/GMP regulated environment.
  • Excellent oral and written communication skills.
  • The ability to work as a member of a multidisciplinary team.
Apply Now

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

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

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

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

Travel

  • None
Apply Now
Load more
Show less

A Team That’s Making A Difference.

150+

Issued or Allowed Patents

275+

Patent Applications Filed

142+

Millon Raised