Senior Design Assurance Engineer

985fm.ca

Plymouth, MN, United States
$120,450 - $176,660; bonus/equity: cash-based ince...
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.
  • 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.
  • Our total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, parental leave, 401(k) with company matching, and paid time off.

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 with immediate eligibility

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 negotiation skills
  • Coaching and team leadership
  • Open and honest communication
  • Customer success focus
  • Innovation and better solutions

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

Work Rights

Not specified

Tailored Resume

Cover Letter