Description

You own quality engineering processes across the medical device lifecycle.

Responsibilities

• Lead Design Control activities, covering inputs, outputs, verification, validation, and design transfer.
• Facilitate risk management, developing Risk Management Plans, Hazard Analysis, and DFMEAs for orthopedic products.
• Approve V&V plans, protocols, and reports, ensuring compliance via mechanical and anatomical lab testing.
• Ensure product transfer to production by reviewing manufacturing documentation and assisting with IQ/OQ/PQ.
• Lead root cause investigations and quality problem-solving for design issues, complaints, and CAPAs.

Required Skills

• 6 to 10 years of experience in medical device roles with a Bachelor's degree in mechanical or biomedical Engineering.
• OR 6+ years of experience with a Master's degree in mechanical or biomedical Engineering.
• Strong understanding of FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Proficiency in Geometric Dimensioning and Tolerancing (GD&T) and machining methodologies (titanium and stainless steel).
• Experience with Design History Files (DHF) and Device Master Records (DMR).
• Experience utilizing statistical software tools like MiniTab for data and risk analysis.
• Demonstrated ability to lead cross-functional teams in complex problem-solving.

Preferred Skills

• Certified Quality Engineer (CQE) or Certified Six Sigma Green/Black Belt.
• Experience with EU MDR regulatory submissions or surgical instrumentation/implantable devices.

Key Skills

Education

Bachelor's degree