Senior Design Assurance Engineer

809

$120,450 - $176,660; not specified; not specified ...
Iso 13485
Iso 14971
Fda quality system regulations
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.
  • 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

$120,450 - $176,660; Not specified; Not specified

Skills & Requirements

Must-have

  • ISO 13485
  • ISO 14971
  • FDA Quality System Regulations
  • design controls
  • risk management
  • design verification and validation

Nice-to-have

  • collaboration
  • negotiation
  • conflict resolution
  • coaching
  • 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 and drawings
  • Proficiency in statistical methods
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter