Senior Design Assurance Engineer

H1BConnect

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

$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
  • Process Validation Protocols
  • Supplier Risk Management
  • Root Cause Analysis
  • Statistical Methods

Nice-to-have

  • Customer success focus
  • Innovation and collaboration
  • Respectful interaction
  • Open and honest communication
  • Integrity in actions

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 7-10 years of experience
  • FDA Quality System Regulations knowledge
  • ISO 13485 knowledge
  • Medical Device Directive knowledge
  • Proficiency in statistical methods
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter