Medical Device Engineer II Job at Gateway Recruiting, INC., Mountain View, CA

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  • Gateway Recruiting, INC.
  • Mountain View, CA

Job Description

Job Description

Job Description

Responsibilities:

  • 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 schematics

Skills 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 travel

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