Senior Design Assurance Engineer

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$120,450 - $176,660; bonus/equity: cash-based ince...
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.
  • The total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, cash-based incentive program, and comprehensive benefits.

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; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with match, paid time off, holidays

Skills & Requirements

Must-have

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

Nice-to-have

  • Collaboration and Inclusion
  • Customer Success Focus
  • Innovation and Better Solutions
  • Open and Honest Communication

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 quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter