Senior Design Assurance Engineer

661

Plymouth, MN, United States
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.
  • As a quality Core Team member, plays a key role on development project teams, performing quality/reliability engineering activities while providing guidance and expert advice.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including a comprehensive benefits package with immediate eligibility.

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

Skills & Requirements

Must-have

  • ISO 13485
  • FDA Quality System Regulations
  • ISO 14971
  • Risk Management
  • Design Controls
  • Statistical Methods

Nice-to-have

  • Collaboration
  • Inclusion
  • Integrity
  • Innovation
  • Customer Focus
  • Lean Sigma Tools

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 7-10 years of experience
  • Medical device sterilization process experience
  • Experience interpreting design schematics
  • Proficiency in statistical methods
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter