Senior Design Assurance Engineer

A Totalplumbing

$120,450 - $176,660; bonus/equity: cash-based ince...
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. Performs quality/reliability engineering activities while providing guidance and expert advice to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
  • 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; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, 80 hours holidays, paid time off

Skills & Requirements

Must-have

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

Nice-to-have

  • Customer success focus
  • Innovation and collaboration
  • Respectful interaction
  • Open and honest communication
  • Integrity in actions

Key Requirements

  • 7-10 years of experience
  • Bachelor's Degree in Engineering
  • Master's Degree preferred
  • Experience interpreting design schematics
  • Proficiency in statistical methods
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter