Senior Design Assurance Engineer

576

Plymouth, MN, United States
$120,450 - $176,660; not specified; not specified ...
Fda quality system regulations
Iso 13485
Medical device directive
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; Not specified

Skills & Requirements

Must-have

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

Nice-to-have

  • Collaboration and negotiation skills
  • Team leadership and coaching
  • Effective communication and presentation
  • Lean Sigma tools proficiency

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 7-10 years of experience
  • Master's Degree preferred
  • Experience interpreting design schematics and drawings
  • Proficiency in statistical methods
  • Experience with FDA and European regulated medical devices preferred

Work Rights

Not specified

Tailored Resume

Cover Letter