Senior Design Assurance Engineer

Integer

Base: $120,450 - $176,660; bonus/equity: cash-base...
Iso 13485
Fda quality system regulations
Iso 14971
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures

Job Summary

  • The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
  • Leads Risk Management (ISO 14971) and Usability program activities.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.

Matching Summary

The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.

Salary

Base: $120,450 - $176,660; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, 80 hours holidays, paid time off

Skills & Requirements

Must-have

  • ISO 13485
  • FDA Quality System Regulations
  • ISO 14971
  • Risk Management
  • Design Controls
  • Process Validation

Nice-to-have

  • Collaboration and negotiation skills
  • Coaching and team leadership
  • Customer success focus
  • Innovation and better solutions

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 7-10 years of experience
  • Master’s Degree preferred
  • Experience with FDA and European regulated medical devices preferred
  • Proficiency in statistical methods
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter