Sr. Quality Engineer, Design Assurance – Shockwave (reducer)

Johnson & Johnson

New Brighton, Minnesota, United States
Base: $79,000.00 - $127,650.00; bonus/equity: not ...
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Design verification and validation (v&v)
Risk management in accordance with iso 14971
Failure modes and effects analysis (fmea)
** Johnson & Johnson is seeking a Senior Quality Engineer for Design Assurance at their New Brighton, Minnesota facility, focusing on innovative medical devices for cardiovascular treatments. The ideal candidate will have extensive experience in quality engineering, particularly in design verification and validation, and will work collaboratively across multiple departments to ensure compliance with regulatory standards. **

Job Summary

  • Ensure medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality system and regulatory requirements.
  • Partner closely with R&D, Manufacturing, Regulatory Affairs, Clinical Affairs, and Marketing to provide hands-on Design Assurance support throughout new product development.
  • Provide practical, execution-focused quality engineering support with an emphasis on risk management, verification and validation oversight, and design transfer, enabling timely and compliant product launches.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Senior Quality Engineer for Design Assurance at their New Brighton, Minnesota facility, focusing on innovative medical devices for cardiovascular treatments. The ideal candidate will have extensive experience in quality engineering, particularly in design verification and validation, and will work collaboratively across multiple departments to ensure compliance with regulatory standards. **

Salary

Base: $79,000.00 - $127,650.00; Bonus/Equity: Not specified; Benefits: Pension, 401(k), Long-term incentive program, Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Design Verification and Validation (V&V)
  • Risk Management in accordance with ISO 14971
  • Failure Modes and Effects Analysis (FMEA)
  • ISO 13485 and FDA GMP compliance
  • Statistical analysis and Minitab proficiency

Nice-to-have

  • Cardiovascular or interventional product experience
  • Familiarity with balloon catheter devices
  • Experience with regulatory submissions
  • Knowledge of human factors principles
  • Lean or Six Sigma certification

Key Requirements

  • Bachelor's degree with 5+ years or Master's with 3+ years of medical device industry experience
  • Experience with Test Method Validation (TMV)
  • Working knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR
  • Experience supporting regulatory inspections and audits

Work Rights

Not specified

Tailored Resume

Cover Letter