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