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

Johnson & Johnson

New Brighton, Minnesota, United States
Base: $79,000.00 - $127,650.00; bonus/equity: elig...
Iso 13485 compliance expertise
Design verification and validation oversight
Risk management per iso 14971
The Senior Quality Engineer will ensure medical devices are designed, developed, and transferred to manufacturing in compliance with quality system and regulatory requirements

Job Summary

  • The Senior Quality Engineer will ensure medical devices are designed, developed, and transferred to manufacturing in compliance with quality system and regulatory requirements.
  • This role partners closely with R&D, Manufacturing, and Regulatory Affairs to provide hands-on Design Assurance support throughout the new product development lifecycle.
  • Employees are eligible for a comprehensive benefits package including 401(k) matching, long-term incentives, and up to 480 hours of parental leave.

Matching Summary

The Senior Quality Engineer will ensure medical devices are designed, developed, and transferred to manufacturing in compliance with quality system and regulatory requirements.

Salary

Base: $79,000.00 - $127,650.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: 401(k), pension, vacation, sick time, and parental leave

Skills & Requirements

Must-have

  • ISO 13485 compliance expertise
  • Design Verification and Validation oversight
  • Risk Management per ISO 14971
  • FDA GMP and QMSR knowledge
  • Statistical analysis with Minitab

Nice-to-have

  • Class II or III device experience
  • Cardiovascular product background
  • PLM system proficiency Windchill
  • Lean Six Sigma certification
  • Human factors engineering knowledge

Key Requirements

  • Bachelor's degree with 5+ years experience
  • Master's degree with 3+ years experience
  • Hands-on V&V and Test Method Validation experience
  • Experience with FDA audits and inspections
  • Strong technical writing skills for DHFs

Work Rights

Not specified

Tailored Resume

Cover Letter