- 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
- 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
- Bachelor's or higher-level STEAM degree, Physics, or related field, or demonstrated equivalent experience
- 2+ years of product development experience in medical device
- 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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Medical Device Engineer II - Mountain View, United States - Gateway Recruiting, INC.
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Job Description
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