Medical Device Engineer II

Responsibilities:

1. 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.)
2. Establish and maintain risk management documentation (risk management plan, hazards analyses, failure mode, and effects analyses) for development projects in accordance with ISO 14971
3. 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.
4. Review deliverables from vendors, such as technical drawings, technical reports, etc.
5. Generate technical protocols and reports
6. Develop validation master plans, IQ/OQ/PQ protocols, and reports for test fixtures and manufacturing equipment
7. 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 devices

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