Careers

Requirements

• Develop concepts and ideas for improving existing 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 a 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

Education and/or Job Experience

• 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

Requirements

• Actively participate in early design concept review with R&D to provide objective feedback to ensure manufacturing robustness.
• Work closely with Engineering and Manufacturing to understand design intent and incorporate
• Geometric Dimensioning and Tolerancing (GD& T).
• Design new jigs and fixtures for manufacturing.
• Develop standards and key performance metrics to reduce variability as well as improve quality, throughput, and efficiency.
• Perform tests and experiments when necessary to collect functional data as it relates to the current tool design.
• Perform equipment characterization and define process windows by creating appropriate DOEs and utilizing statistical data analysis.
• Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution.
• Provide support to existing equipment and ensure proper documentation and training.
• Lead new product transfer and manufacturing scale-up activities utilizing best manufacturing techniques.
• Adhere to project timelines, identify risks/issues, and recommend mitigations.
• Collaborates with coworkers across the organization to document and design how systems work and interact.
• Clearly communicates technical issues, and ties work clearly to company objectives.
• Proactively offer regular, constructive feedback to others.
• Participate in recruiting strong engineers.
• Comply with company’s policies and guidelines regarding design control, validation activities and documentation.

Education and/or Job Experience

• Bachelor’s Degree in Mechanical, Chemical, Manufacturing, or related engineering fields.
• 10-12 years hands-on experience in a manufacturing environment with a proven record of process development, optimization, and validation.

Skills and Specifications

• Proficiency with SolidWorks required.
• Prior experience in a medical device company.
• Experience with design control process for medical devices and implementation of product into manufacturing.
• Good understanding of DFM and lean manufacturing.
• Knowledge and experience with plastic injection molding.
• Knowledge and hands-on experience with machine shop tools .
• Excellent verbal, written, and 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.

• Lead continuous improvement programs to improve, manufacturing processes, equipment performance and reliability. Maximize Mean Time Between Failure (MTBF), Operational Uptime and minimize Mean Time To Repair (MTTR)
• Support Subject Matter Experts (SMEs) during the design and development of new equipment.  analyze equipment malfunctions and failures and accordingly develop corrective actions
• Develop improvements to enhance equipment reliability and scalability
• Develop preventive maintenance procedures to reduce equipment and tooling failures
• Maintain documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
• Responsible for manufacturing methods and their transfer into production
• Follow SOP on re-validation of existing equipment, tooling and processes
• 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
• Work with Quality Control team to generate, update and implement all manufacturing engineering related requests, vendor contact and auditing specification
• Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
• Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
• Complete projects, report status, and document lessons learned in an efficient manner

Education and/or Job Experience

• BS in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or similar related field
• 5+ years of engineering experience in manufacturing, design, and assembly
• 2+ years of experience in Design for Excellence (DFX), Electromechanical equipment, Electrothermal equipment, and various testing equipment
• 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.

Preferred Qualifications

• Master’s degree in engineering
• 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

Responsibilities

• Develop concepts and ideas for improving exiting tooling as well as creating new tooling including semi-automation where applicable
• Take full ownership of the design, conduct concept reviews, show proof of concept through prototyping/supporting test data, and support the validation activities
• Create 3D models, engineering drawings and bills of materials
• Create work instructions and manufacturing SOP’s
• 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
• 1-3 years of hands-on, relevant experience
• Experience with mechanical/electromechanical design
• Experience with precision mechanisms, pneumatics, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
• Experience with creating engineering drawings, BOMs and product specifications
• Knowledge of material properties, heat treatment and surface finish
• Strong analytical and problem-solving skills
• Knowledge and/or hands-on experience with machine shop tools
• Knowledge of GD&T as well as proficiency with SolidWorks
• Excellent verbal, written, presentation and interpersonal 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 or equivalent
• Knowledge/experience with plastic injection molding
• Knowledge/experience with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP and QMS standards

Requirements

• Coordinating all public relations activities
• Developing a communications plan including strategy, budget, and tactics to support company goals
• Developing a media relations strategy, seeking high-level placements in print, broadcast, and online media
• Collaborating with the company’s external Public Relations firm to establish strong media presence
• Leverage existing media relationships and cultivate new contacts within business and industry media
• Coordinate with internal teams regarding publications and social media activities
• Monitor, analyze and report on media coverage
• Monitor, analyze and report on progress and results of communications and public relations strategy and activities on a regular basis
• Maintain a keen understanding of industry trends affecting clients and make appropriate recommendations regarding communication and public relations strategy surrounding them

Education and/or Job Experience

• 6+ years of proven working experience in public relations or journalism required, specifically within the biotech / pharmaceutical industry
• Proven track record designing and executing successful public relations campaigns
• Strong relationships with both local and national business and industry media outlets
• Experience in acting as a company spokesperson; comfortable and skilled in both broadcast and print media interviews
• Exceptional writing and editing skills
• BA/MA degree in Marketing, Advertising, Communications, or a related discipline

Requirements

• Develop concepts and ideas for improving existing 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.
• Able to rapid prototype custom, in-house made machines.
• 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 a 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.

Education and/or Job Experience

• Bachelor’s Degree in Mechanical Engineering.
• 2 – 5 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, SCADA, Ladder Logic preferred.

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

Responsibilities

• Design and implement equipment upgrade to improve reliability and increase production output.
• Lead or be an active team member to drive continuous improvement programs to improve equipment performance and reliability, maximize Mean Productive Time Between Failure (MTBF), and Operational Uptime (AOU), and minimize Mean Time To Repair (MTTR).
• Take ownership of the new equipment specification, technical negotiation with vendors, design and documentation review, installation, and qualification testing and documentation.
• Ensure project is on schedule, and at the same time deliver with the highest quality by proactively identifying and correcting capability, reliability, and Maintenance issues early on.  Document lessons learned in an efficient manner.
• Develop preventive maintenance procedures to reduce equipment and tooling failures
• Generate and maintain accurate and detailed documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
• Follow SOP on re-validation of existing equipment, tooling and processes
• Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
• Support equipment related projects which includes but not limited to:
• Purchasing of new or used equipment, set-up, qualification, and release in production.
• Manage multiple projects in manufacturing environment from maintenance of existing machines to specifying, purchasing, and set up of new equipment.
• Integration of different equipment aspects (software and hardware).
• BS, or MS degree in mechanical engineering, electrical engineering, computer engineering or equivalent
• 7+ years of experience in Equipment Engineering supporting high volume manufacturing.
• Good hands-on systems integration experience, troubleshooting, and start-up and commissioning of equipment into production environment.
• Proficient in Solidworks, Autocad, and GD&T.
• Experienced in PLC, HMI, motion control, instrumentation, pneumatics, and material handling, including robotics. Allen Bradley, Mitsubishi, Omron, Siemens, Adept or Epson experience is a plus.
• Working knowledge of lean manufacturing.
• Superior communication skills, (written, verbal and active listening.)
• Highly motivated self-starter, capable of self-management with little to no oversight
• Strong interpersonal skills and proven ability to establish effective cross-functional working relationships. Ability to effectively participate on multi-disciplinary teams and projects.
• 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. is a plus.

Qualifications

• 7+ years of manufacturing and Equipment Engineering support in a high volume manufacturing, Medical Device or related industry
• Experience with operation of Microvue and inspection programs
• Experience with soldering and electrical repairs
• Proficient in Solidworks, Autocad, and GD&T.
• Experienced in PLC, HMI, motion control, instrumentation, pneumatics, and material handling, including robotics. Allen Bradley, Mitsubishi, Omron, Siemens, Adept or Epson experience is a plus.
• Working knowledge of lean manufacturing.
• Superior communication skills, (written, verbal and active listening.)
• Highly motivated self-starter, capable of self-management with little to no oversight
• Strong interpersonal skills and proven ability to establish effective cross-functional working relationships. Ability to effectively participate on multi-disciplinary teams and projects.
• 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. is a plus.
• Experience with performing strength/strain tests
• Experience with micro-assembly
• Comfortable with using microscopes
• Must be hands-on and be able to perform all aspects of aseptic manufacturing
• Effective verbal and written communication
• Ability to work on flexible schedule
• Comfortable using Microsoft Office

Responsibilities

• Evaluate the current design and identify opportunities to realize improvement in product consistency and increased throughput in a manufacturing environment
• Show proof of concept through prototyping and supporting test data, and coordinate implementation with appropriate stakeholders
• Take full ownership of documentation by following internal design control SOPs, leading verification/validation activities, and participating in phase reviews
• Create 3D models, engineering drawings and bill of materials
• Create comprehensive work instructions and manufacturing SOP’s
• Work with quality to resolve any issues with components or processes
• Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
• Comply with company’s policies and guidelines regarding quality and regulatory

Qualifications

• Bachelor’s Degree in Mechanical Engineering
• 5 plus years hands-on experience in a design environment
• Experience with creating engineering drawings, BOMs, and product specifications
• 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 in to manufacturing
• Working knowledge of FDA regulations and ISO, cGMP, 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
• Proficiency with SolidWorks required
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

• Knowledge /experience with plastic injection molding
• Masters’ degree or higher in Mechanical Engineering or Biomedical Engineering

Requirements

• This individual will be responsible for supporting the Product Lifecycle, Design Control, and Design Transfer processes, as well as the quality elements of design projects
• Provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles
• Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations
• Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.)
• Lead test method validation activities and Gage R&R studies for Combination Product
• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification
• Identify quality characteristics and validation criteria for components, subassemblies, and finished product
• Work with R&D in the creation of requirements for new products and engineering specifications
• Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971
• Provides direction to Engineering to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards within the area of Design Controls
• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports
• Support quality assurance activities, including, but not limited to: internal and external audits, NCMRs and CAPAs,
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
• Other duties/ activities may be necessary to support departmental or company goals

Education and/or Job Experience

• A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required
• BS degree in Mechanical Engineering or related field is required
• Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485
• Experience with Risk Management process (Risk Management Plan/Report, FMEA’s) and associated standards (ISO 14971:2019)
• Understanding of multiple technology areas (software, mechanical, electrical, biomedical, test automation, etc.)
• Must be a self-starter and capable of working independently and within a team.
• Experience performing statistical analysis (Six Sigma preferred)
• 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
• Exceptional problem-solving skills
• Understands and can subsequently explain complex quality details to non-experts

Requirements

• Support all CMC activities quality control business process build out, including but not limited to the establishment of technical operations, qualification/validation and execution analytical methods, method validations, method transfers, material specifications, stability data, expiry date extensions, and cleaning validations
• Ensure activities and deliverables are in compliance with applicable FDA, EMA and GxP regulations, ICH guidelines, Rani procedures, and industry best practices
• Support internal and external GMP manufacturing along with oversight of GMP sample handling, testing, QC stability program, QC release and stability data analyses, OOE/OOS investigations, deviations, CAPAs and support certificates of analysis generation for drug products
• Foster a quality and continuous improvement mindset to ensure that all QC deliverables are cGMP compliant in a phase appropriate fashion to support clinical and commercial programs
• Provide quality oversight related to GMP activities including approval of method validation, specifications, release testing for raw materials, intermediates, excipients, APIs, and drug products
• Oversee work at external contract labs/vendor analytical labs, including method development, qualification, transfer, and validation
• Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality risks, including application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality
• Manage supplier qualification and requalification activities for CROs and CDMOs
• Ensure robust processes are implemented for management of clinical and commercial product and process lifecycle quality (e.g., control strategy, technology transfer, process validation lifecycle, quality monitoring)
• Support continuous collaboration with analytical development, technical operations, manufacturing, QA, regulatory affairs, clinical development, and program management, as well as external vendors (CROs and CDMOs)
• Close engagement with analytical development to build a sustainable GMP quality control platform to support commercial and growing portfolio of clinical development programs
• Support quality review of CMC sections of regulatory filings and participate in inspection readiness efforts

Education and/or Job Experience

• PhD in a scientific discipline with 7+ years or MS/BS degree with 10+ years of experience in Analytical Development/Quality Control in a GxP pharmaceutical environment
• A proven track record of implementing phase appropriate quality control strategies, method validation and specification development
• Working knowledge of cGMP requirements including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO), as well as pharmacopeia standards
• Direct experience in managing analytical development/QC activities at CROs and CDMOs
• CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics and/or combination products
• Expert knowledge of cGMP compliance regulations and industry practices for US/EU
• Previous experience with combination products preferred
• Proficient in risk assessment and root cause analysis tools
• Demonstrate keen understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives

Qualifications

• 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
• Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organization
• Collaborative, goal-oriented, and an ability to work in a fast-paced environment
• Must be strategic as well as hands-on
• Attention to detail and organizational skills
• Must demonstrate ability to work independently, make effective decisions

Requirements

• Lead continuous improvement programs to improve, manufacturing processes, equipment performance and reliability. Maximize Mean Time Between Failure (MTBF), Operational Uptime and minimize Mean Time To Repair (MTTR)
• Support Subject Matter Experts (SMEs) during the design and development ofnew equipment.  analyze equipment malfunctions and failures and accordingly develop corrective actions
• Develop improvements to enhance equipment reliability and scalability
• Develop preventive maintenance procedures to reduce equipment and tooling failures
• Maintain documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
• Responsible for manufacturing methods and their transfer into production
• Follow SOP on re-validation of existing equipment, tooling and processes
• 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
• Work with Quality Control team to generate, update and implement all manufacturing engineering related requests, vendor contact and auditing specification
• Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
• Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
• Complete projects, report status, and document lessons learned in an efficient manner

Education and/or Job Experience

• BS in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or similar related field
• 5+ years of engineering experience in manufacturing, design, and assembly
• 2+ years of experience in Design for Excellence (DFX), Electromechanical equipment, Electrothermal equipment, and various testing equipment
• 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.

Preferred Qualifications

• Master’s degree in engineering
• 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

Requirements

• Follow-up on existing purchase orders with suppliers based on aging report to monitor status of open purchase orders to ensure on-time delivery of all materials, including timely resolution, communication, and request certificates and safety data sheets as needed.
• Assist in resolving issues regarding PO to invoice discrepancies, returns and quality problems with suppliers.
• Maintain purchase order files.
• Open, track and close manufacturing and engineering work orders.
• Update work orders LHR’s in WIP, that are “Must Conform”, per ECO disposition.
• Scan work orders as needed.
• Assist stockroom in kitting work orders and data entry as needed.
• Run daily open work order reports.
• Perform system transactions as needed.
• Excellent attention to detail.
• Ensure and promote compliance to Company and Procurement policies and procedures.
• Ensure compliance to Rani Quality systems and QSR.

Education and/or Job Experience

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

Responsibilities

• Update and maintain fixed asset and depreciation schedules along with property tax filings
• Reconciles bank accounts by gathering and balancing information
• Update and maintain prepaid and amortization schedules
• Execute monthly accounting close procedures and deliverables (journal entries, reconciliations, reports)
• Assist with reviewing of expenses and posting journal entry adjustments
• Assist with sales and use tax accrual along with filing returns
• Assist with reconciling credit cards and expense reports
• Ensure that transactions are accurately and timely reflected in the financial statements
• Assist senior accountant in the preparation of monthly/quarterly/yearly closings
• Assist with other accounting projects as needed

Requirements and skills

• Willingness to meet deadlines on a consistent basis
• Excellent organizational skills and attention to detail
• Ability to identify a problem and resolve it
• Good understanding of accounting and financial reporting principles and practices
• High degree of accuracy
• Desire for continual growth and learning
• Proficient in the use of Microsoft Excel, including Vlookups and pivot tables
• Familiarity with accounting software and other relevant computer software
• BS/BA degree in accounting, finance or relevant field
• 3+ years of experience

Responsibilities

• Prepare & post monthly journal entries
• Perform account reconciliation and analysis of various GL accounts
• Review assumptions and judgments underlying significant estimates
• Review and reconcile intercompany accounts
• Reconcile cash and produce weekly cash reporting
• Support month-end, quarter-end, and year-end accounting close
• Assist in year-end audits & quarterly reviews
• Work with FP&A on accounting issues and perform analytical reviews
• Implement and ensure compliance with internal accounting control requirements
• Identify internal process improvements and opportunities for automation
• Perform other related Ad Hoc projects as required

Education, Skills & Experience

• Bachelor’s degree in Accounting or Finance is required
• 5 to 7 years general ledger accounting experience within publicly traded companies is preferred
• Working knowledge with GAAP
• Experience with QAD or large ERP is preferred
• Experience with SOX is preferred
• Strong attention to detail and excellent follow-through skills
• Good communication and organizational skills
• Ability to multi-task, prioritize work and meet deadlines
• Experience in high-tech background a plus
• Good team player

Requirements

• Oversees and perform monthly close process, including preparing and reviewing monthly reconciliations for balance sheet accounts and posting journal entries. Perform budget to actual analyses and dashboards for the executive team and board on a timely basis.
• Lead the day-to-day management of accounting operations with a focus on efficient processes that support business needs including purchasing/AP, and reporting.
• Together with the Controller, lead public-company reporting requirements, including management of the external audit and preparation of financial statements for SEC filings.
• Assist in developing internal SOX control guidelines, policies and procedures; works with accounting team to ensure compliance.
• Analyzing and implementing improvements to financial and operating performance, accounting policies and management reporting processes.
• Takes lead role in completing annual internal and external audits.
• Oversees the completion of all federal and state tax and regulatory filings.
• Reviews and manages daily operating cash balances. Prepares cash forecasts as needed
• Oversees accounts payable, expense reports, and payroll, including payroll tax related matter for stock-based compensation.
• Leads and/or assists with special projects as needed.
• Recommends new approaches, procedures, and processes to effect continual improvements.
• Looks for ways to automate processes and leverage the Company’s ERP system.

Education and/or Job Experience

• 12+ progressive accounting experience, including 5+ years of managerial and hands-on general ledger accounting and audit experience
• Excellent knowledge of GAAP accounting principles, practices, and applications, strongly preferred within a public company (GL/Close, AP, AR, Consolidations), revenue recognition, inventory accounting experience, clinical trials related accruals, lease accounting, debt and equity (debt issuances, stock-based compensation, and warrant accounting)
• A proactive approach to scaling processes, optimizing system-based solutions, and anticipating need of growth-stage company
• Experience preparing financial statements and completing regular and accurate monthly closes, including account reconciliations and general ledger maintenance
• Experience overseeing accounts payable processing, expense reporting and payroll
• Must be able to collaborate, effectively communicate, and build positive relationships with other teams within the finance team, as well as cross-functionally outside finance to effectively make recommendations, implement process improvements, etc.
• Knowledge of relevant federal, state, and local laws, codes, and regulations
• Strong knowledge of Microsoft Word and Excel
• Strong track record of successfully motivating, developing, and helping people reach their full potential

Preferred Qualifications

• Active CPA or Chartered Accountant certification
• Experience using QAD accounting software or a similar accounting package and Paylocity payroll systems
• SEC reporting, technical accounting experience, and deep subject matter expertise in SOX404(b) (highly desired).
• Public company biotechnology experience
• Experience in SEC reporting tools/platforms such as ActiveDisclosure

Competencies

• Systems and process expert—ability to assess processes and systems to identify opportunities for improvement, make innovative data informed recommendations for process improvements and drive forward implementation of new processes allowing for flexibility and iteration.
• Innovator—ability to think “out of the box” and drive innovative and creative thinking and problem solving within the team.
• Project manager—ability to manage multiple projects involving multiple stakeholders, establish and manage shifting priorities, anticipate roadblocks, including external and internal.
• Analytical accounting professional—ability to apply GAAP concepts, establish appropriate standards based accounting policies, and create GAAP compliant financial statements. Ability to identify, research, and apply non profit regulatory compliance requirements.
• Empathetic and effective team leader—ability to build and manage a high performing team; build trust, set goals, and provide clear and consistent feedback to foster staff growth. Ability to build authentic relationships to foster an engaged, connected and inclusive team culture where every member feels and is driven by the value they bring to the organization and the mission.

Requirements

• Produce mechanical parts utilizing CNC vertical machining center, manual lathes and mills, and other machine shop equipment.
• Experience working with a wide variety of materials, including Aluminum, Tool Steels, Stainless, and plastics such as acetal, polycarbonate, and PEEK.
• Ability to manufacture extremely small parts, ranging from 0.005” to 0.100” with tolerance down to 0.0002”.
• Expert knowledge working with computer numerical control (CNC) machine.
• Determine the fixtures, attachments, and tools necessary to complete jobs according to specifications, and mount them to machine prior to beginning cutting.
• Discuss project specifications with engineers and supervisors to guarantee consistency between plans and products and collaborate to modify designs when existing ones are not feasible.
• Modify machine speed, tooling and cutting style to ensure precision and accuracy of manufactured parts. Understand tooling and tooling geometry.
• Oversee cutting process and make adjustments throughout each job, catch mistakes as they happen and take necessary measures to eliminate errors.
• Supervise machine temperatures, ensure that machine has adequate warm-up and cool-down time between jobs. Monitor coolant mix rate and adjust accordingly.
• Review and interpret cutting plans, enter them into control outlets before jobs and alter them to correct mistakes when necessary.
• Inspect all finished products for accuracy and uniformity to ensure product quality.
• Assembly, troubleshoot, and integrate components into systems as required.
• Understanding and ability to set up basic test equipment, test tools, and measurement equipment such as micrometers, calipers, test indicators, optical comparators, and other precision equipment.
• Perform periodic preventive maintenance of equipment and inventory of tooling.
• Maintains safe operations by adhering to safety procedures and regulations, and ensuring a safe work environment for others as required by both machine manufacturer and company policies
• Follows company SOP’s, work instructions, and any other Quality Assurance documentation as directed for operations.

Education and/or Job Experience

• Technical degree or certificate in machine shop technology, machine tool technology/machinist
• 5+ years of experience working in a machine shop in environment

Qualifications

• Capable of reading and understanding mechanical drawings and GD&T
• Ability to follow detailed written and/or verbal work instructions
• Working knowledge of SolidWorks, Mastercam, or other related CAD/CAM software
• Ability to prioritize tasks and multitask in a fast-paced environment
• Must demonstrate strong interpersonal and communication skills
• Strong analytical and problem-solving skills
• Attention to detail and quality of work
• Willingness to learn new technology and contribute to a positive team spirit
• Creative, self-motivated, and flexible to work in a small company environment and assume a wide variety of tasks