Senior Design Quality Engineer

Boston Scientific Foundation Inc

Marlborough, MA, US
Base: $89,200 - $169,500; bonus/equity: annual bon...
On-site
5+ years medical device engineering experience
Iso 14971 risk management compliance
21 cfr part 820 regulatory knowledge
The role supports medical device product development from concept through commercialization while ensuring safety, quality, and compliance

Job Summary

  • The role supports medical device product development from concept through commercialization while ensuring safety, quality, and compliance.
  • Candidates will lead risk management deliverables to ensure adherence to ISO 14971 and demonstrate a primary commitment to patient safety.
  • This hybrid position requires working onsite at least three days per week in Marlborough, Massachusetts.

Matching Summary

The role supports medical device product development from concept through commercialization while ensuring safety, quality, and compliance.

Salary

Base: $89,200 - $169,500; Bonus/Equity: Annual bonus target and long-term incentives for exempt roles; Benefits: Core and optional employee benefits available

Skills & Requirements

Must-have

  • 5+ years medical device engineering experience
  • ISO 14971 risk management compliance
  • 21 CFR part 820 regulatory knowledge
  • EN ISO 13485 quality system standards
  • Hybrid onsite work in Marlborough MA

Nice-to-have

  • Six Sigma certification preferred
  • Minitab statistical analysis proficiency
  • Strong leadership and coaching skills
  • Cross-functional project team influence
  • Strategic mindset with execution focus

Key Requirements

  • BS in Biomedical or Mechanical Engineering
  • Minimum 5 years medical device experience
  • Knowledge of EU MDR and US regulations

Work Rights

Not specified

Tailored Resume

Cover Letter