Senior Design Assurance Engineer

724842

Plymouth, MN, United States
$120,450 - $176,660; not specified; comprehensive ...
Iso 14971 risk management
Fda quality system regulations
Iso 13485
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

$120,450 - $176,660; Not specified; Comprehensive benefits package

Skills & Requirements

Must-have

  • ISO 14971 Risk Management
  • FDA Quality System Regulations
  • ISO 13485
  • Medical Device Directive
  • Design Verification and Validation
  • Process Validation Protocols

Nice-to-have

  • Collaboration and negotiation skills
  • Coaching and team leadership
  • Lean Sigma tools proficiency
  • Statistical methods expertise

Key Requirements

  • 7-10 years of experience
  • Bachelor’s Degree in Engineering or related field
  • Master’s Degree preferred
  • Experience interpreting design schematics and drawings
  • Proficiency in statistical methods
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter