Senior Design Assurance Engineer

Integer

Base: $120,450 - $176,660; bonus/equity: cash-base...
Fda quality system regulations knowledge
Iso 13485 and iso 14971 standards
Risk management and dfmea expertise
The primary purpose of this job is to support new product development to ensure design performance meets FDA and European regulatory requirements

Job Summary

  • The primary purpose of this job is to support new product development to ensure design performance meets FDA and European regulatory requirements.
  • The Design Assurance Engineer will lead risk management activities, usability programs, and cross-functional teams to mitigate risks throughout the device lifecycle.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching contributions.

Matching Summary

The primary purpose of this job is to support new product development to ensure design performance meets FDA and European regulatory requirements.

Salary

Base: $120,450 - $176,660; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and paid time off

Skills & Requirements

Must-have

  • FDA Quality System Regulations knowledge
  • ISO 13485 and ISO 14971 standards
  • Risk Management and DFMEA expertise
  • Design Verification and Validation protocols
  • Statistical methods proficiency ANOVA SPC DOE

Nice-to-have

  • Master's Degree in Engineering preferred
  • Experience with European medical device regulations
  • Strong collaboration and negotiation skills
  • Lean Sigma tools application experience
  • Ability to lead cross-functional teams

Key Requirements

  • Bachelor's Degree in Engineering required
  • 7-10 years of relevant experience
  • Practical knowledge of FDA and ISO regulations

Work Rights

Not specified

Tailored Resume

Cover Letter