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San Francisco Bay Area, CA

  • Senior or Principal Manufacturing Process Engineer

    Pleasanton, CA

    Summary:
    Design and develop manufacturing processes, tooling, and fixtures in order to meet pilot manufacturing schedules while enhancing productivity and product quality. Candidate will work closely with engineering team to support R&D design transfer to pilot manufacturing.

    Principal Tasks & Responsibilities:
    1. Transfer R&D device into pilot manufacturing. Responsible for process optimization, prototype fabrication and process development.
    2. Develop processes using DOE or other methods.
    3. Validate full device processes with IQ, OQ, PQ protocols and reports, statistical analysis.
    4. Develop pilot manufacturing process instructions and validations, and lot history records related to builds, including writing test plans, protocols and reports in conjunction with verification and validation testing.
    5. Write protocols and reports and investigate CAPAs and NCMRs.
    6. Oversee pilot manufacturing line from a technical perspective.
    7. Troubleshoot problems, perform Root Cause Analysis and resolve basic process engineering issues.
    8. Engineer processes to increase efficiencies and yields in pilot manufacturing.
    9. Experience specifying tolerances and conducting tolerance analysis in assemblies.
    10. Responsible for training technicians and assemblers.
    11. Design and build product equipment and tooling.
    12. Vendor and supplier management.
    13. Establish and maintain a QSR-compliant manufacturing environment.
    14. Ensure manufacturing compliance with all ISO, EN, MDD and FDA regulations and requirements.
    15. Participate in the development of FMEA and other risk assessment documentation.

    Qualifications:
    Education: Bachelor’s degree in Mechanical, Manufacturing or Materials Science Engineering required.

    Experience:
    · 4-6 year experience in medical device industry with Class III device or drug combination device.
    · Catheter-based technologies (stent, balloon or microcatheter) experience required.
    · Experience in transfer from R&D to pilot manufacturing.
    · GMP knowledge.

    Skills:
    · Strong writing and communication skills, including good interpersonal skills.
    · Hands-on, reliable and proactive with a positive results-oriented attitude.
    · Team player attitude and ability to work in a small project team setting.
    · Proven track record of resolving materials, process, equipment and training issues on production floor.
    · Proficient with Microsoft Office applications and in CAD design (SolidWorks preferred).

     


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