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Medical Device Engineer II

Company: Gateway Recruiting, INC.
Location: Mountain View
Posted on: March 19, 2023

Job Description:


  • Establish and maintain design history file documentation for development projects (design and development plan, requirements specifications, device master record, IOV matrix, verification, validation summary reports, etc.)
  • Establish and maintain risk management documentation (risk management plan, hazards analyses, failure mode, and effects analyses) for development projects in accordance with ISO 14971
  • Coordinate product testing with vendors (e.g., mechanical shock and vibration, environmental conditioning, ISTA 3A, battery tests, IP22, etc.), including protocol development, sample coordination, and writing test reports.
  • Review deliverables from vendors, such as technical drawings, technical reports, etc.
  • Generate technical protocols and reports
  • Develop validation master plans, IQ/OQ/PQ protocols, and reports for test fixtures and manufacturing equipment
  • Review mechanical drawings and electrical schematicsSkills Required:
    • Excellent technical writing skills
    • Excellent mechanical aptitude and good attention to detail
    • Excellent oral and written communication skills as well as strong interpersonal skills
    • Well-versed in FDA regulations for medical devices and products including Design Controls 21 CFR 820 and MDR
    • Experience working in compliance with GMP regulations
    • Experience with mechanical drawings and electrical schematics preferred -Education and Experience:
      • Bachelor's or higher-level STEAM degree, Physics, or related field, or demonstrated equivalent experience
      • 2+ years of product development experience in medical device -Physical Requirements:
        • Prolonged periods of sitting at a desk and working on a computer
        • Must be able to lift up to 15 pounds at times
        • Must be willing to travelPowered by JazzHR

Keywords: Gateway Recruiting, INC., Mountain View , Medical Device Engineer II, Healthcare , Mountain View, California

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