Senior Design Assurance Engineer

81

Plymouth, MN, United States
$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.
  • Key accountabilities include leading Risk Management (ISO 14971) and Usability program activities, generating and reviewing design verification and validation protocols, and supporting supplier risk management initiatives.
  • The total rewards program includes base salary, a cash-based incentive program, comprehensive benefits with immediate eligibility, parental leave, and a 401(k) plan with company matching contributions.

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: comprehensive benefits package

Skills & Requirements

Must-have

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

Nice-to-have

  • Collaboration and negotiation skills
  • Coaching and team leadership
  • Lean Sigma tools proficiency
  • Medical device sterilization process knowledge

Key Requirements

  • 7-10 years of experience
  • Bachelor’s Degree in Engineering or related field
  • 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