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 leads risk management activities, including ISO 14971 compliance and cross-functional team planning for mitigations.
  • The company offers a comprehensive benefits package including medical, dental, vision, and immediate 401(k) 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, and 401(k) match

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 like ANOVA

Nice-to-have

  • Strong collaboration and negotiation skills
  • Experience with Lean Sigma tools
  • Ability to lead cross-functional teams
  • Excellent technical writing capabilities
  • Master's Degree in Engineering preferred

Key Requirements

  • Bachelor's Degree in Engineering required
  • 7-10 years of experience required
  • Practical knowledge of FDA regulations
  • Proficiency in statistical methods and DOE

Work Rights

Not specified

Tailored Resume

Cover Letter