Senior Design Assurance Engineer

Integer

Base: $120,450 - $176,660; bonus/equity: cash-base...
Fda quality system regulations knowledge
Iso 13485 and iso 14971 expertise
Risk management (dfmea, fta) leadership
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 role involves leading Risk Management activities under ISO 14971 and guiding cross-functional teams through design controls and supplier assessments.
  • Employees receive a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching.

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: Medical, dental, vision, 401(k) match, paid time off

Skills & Requirements

Must-have

  • FDA Quality System Regulations knowledge
  • ISO 13485 and ISO 14971 expertise
  • Risk Management (DFMEA, FTA) leadership
  • Design verification and validation protocols
  • Statistical methods proficiency (ANOVA, DOE)
  • Root cause analysis and CAPA execution

Nice-to-have

  • Master's Degree in Engineering preferred
  • Experience with European regulated devices
  • Strong collaboration and negotiation skills
  • Ability to coach cross-functional teams
  • Excellent technical writing capabilities

Key Requirements

  • Bachelor's degree in Engineering required
  • 7-10 years of relevant experience
  • Practical knowledge of FDA QSR and ISO standards

Work Rights

Not specified

Tailored Resume

Cover Letter