Senior Design Assurance Engineer

486

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.
  • Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations.
  • 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

Base: $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
  • Design Verification and Validation
  • FDA Quality System Regulations
  • ISO 13485
  • Medical Device Directive
  • Root Cause Analysis

Nice-to-have

  • Collaboration and negotiation skills
  • Team leadership and coaching
  • 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
  • Experience with FDA and European regulated medical devices
  • Proficiency in statistical methods
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter