Senior Design Assurance Engineer

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Plymouth, MN, United States
Base: $120,450 - $176,660; bonus/equity: cash-base...
Iso 14971 risk management
Design verification and validation
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, 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

Base: $120,450 - $176,660; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • ISO 14971 Risk Management
  • Design Verification and Validation
  • FDA Quality System Regulations
  • ISO 13485
  • Medical Device Directive
  • Statistical Methods
  • Root Cause Analysis

Nice-to-have

  • Collaboration and Inclusion
  • Customer Success Focus
  • Innovation and Better Solutions
  • Open and Honest Communication
  • 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
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter