Senior Design Assurance Engineer

599

Plymouth, MN, United States
Base: $120,450 - $176,660; bonus/equity: cash-base...
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.
  • We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption 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

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Collaboration and negotiation skills
  • Coaching and team leadership
  • Open and honest communication
  • Respectful interaction

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 7-10 years of experience
  • Practical knowledge of medical device sterilization process
  • Experience interpreting design schematics
  • Proficiency in quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter