Base: $79,000.00 - $127,650.00; bonus/equity: not ...
Design verification and validation (v&v)
Risk management per iso 14971
Regulatory compliance with iso 13485
Johnson & Johnson is hiring a Senior Quality Engineer to support the Shockwave Reducer medical device business in New Brighton, MN, focusing on design assurance and compliance
Job Summary
Johnson & Johnson is hiring a Senior Quality Engineer to support the Shockwave Reducer medical device business in New Brighton, MN, focusing on design assurance and compliance.
The role involves partnering with R&D, Manufacturing, Regulatory Affairs, Clinical Affairs, and Marketing to ensure product development meets quality system and regulatory requirements.
Employees are eligible for competitive benefits including retirement plans, paid time off, parental leave, and participation in long-term incentive programs.
Matching Summary
Johnson & Johnson is hiring a Senior Quality Engineer to support the Shockwave Reducer medical device business in New Brighton, MN, focusing on design assurance and compliance.
Salary
Base: $79,000.00 - $127,650.00; Bonus/Equity: Not specified; Benefits: Retirement plans, paid time off, parental leave, long-term incentive program
Skills & Requirements
Must-have
Design Verification and Validation (V&V)
Risk Management per ISO 14971
Regulatory compliance with ISO 13485
Design History File (DHF) management
Test Method Validation (TMV)
Cross-functional collaboration
Quality system and regulatory oversight
Nice-to-have
Experience with cardiovascular medical devices
Knowledge of human factors and usability engineering
Lean, Six Sigma or DFSS certification
Proficiency with PLM and MES systems
Strong statistical and analytical skills
Technical writing for quality documentation
Support for regulatory submissions
Key Requirements
Bachelor’s degree in biomedical or mechanical engineering with 5+ years experience or Master’s with 3+ years
Hands-on experience in Design V&V and Test Method Validation
Knowledge of FDA GMP, ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR
Experience with FMEA development and risk management
Ability to support FDA, Notified Body, and ISO audits