Lead Design Assurance Engineer – Medical Devices

Regulatory Jobs; New Brighton (MN); Vor Ort; USD 102.000 - 177.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Long‑term incentive program

Zusammenfassung

Johnson & Johnson is seeking a Principal Quality Engineer (Design Assurance) to lead QA for new medical device development in New Brighton, MN. The role partners with R&D, Manufacturing, Regulatory Affairs, and Clinical teams to ensure design compliance and successful product launches.

You will apply ISO 13485, ISO 14971, FDA QMSR requirements, and lead V&V activities, DHF completeness, and risk management. Travel up to 10% may be required.

Qualifikationen

• Bachelor's degree with 10+ years in medical devices.
• Hands-on V&V, TMV, and risk management per ISO 14971.
• Regulatory knowledge: ISO 13485, FDA QMSR, 21 CFR Part 820.
• Strong statistical/analytic skills with hypothesis testing.
• Experience interpreting and applying regulatory requirements.

Aufgaben

• Lead quality assurance for new product development.
• Provide Design Assurance across design reviews and DHFs.
• Oversee V&V activities, protocols, and reports.
• Support design transfer and validation with manufacturing.
• Prepare and participate in FDA/Notified Body audits.
• Collaborate cross-functionally to ensure regulatory compliance.

Kenntnisse

Coaching

Controls Compliance

Critical Thinking

Engineering

Quality Systems

Process Improvements

Quality Validation

Ausbildung

Bachelor’s degree in Biomedical/Mechanical Engineering

Master’s degree in Engineering

Tools

Minitab

Jobbeschreibung

Johnson & Johnson is seeking a Principal Quality Engineer (Design Assurance) to lead QA for new medical device development in New Brighton, MN. The role partners with R&D, Manufacturing, Regulatory Affairs, and Clinical teams to ensure design compliance and successful product launches.

You will apply ISO 13485, ISO 14971, FDA QMSR requirements, and lead V&V activities, DHF completeness, and risk management. Travel up to 10% may be required.