Senior Design Assurance Engineer

457info

$120,450 - $176,660 py
Quality management systems
Iso 14971 risk management
Design verification and validation
Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements

Job Summary

  • Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements.
  • Lead Risk Management (ISO 14971) and Usability program activities, including planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations.
  • The company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

Matching Summary

Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements.

Salary

$120,450 - $176,660

Skills & Requirements

Must-have

  • Quality Management Systems
  • ISO 14971 Risk Management
  • Design Verification and Validation
  • Statistical Methods
  • Root Cause Analysis

Nice-to-have

  • Customer success focus
  • Collaborative team environment
  • Respectful interaction
  • Open and honest communication

Key Requirements

  • 7-10 years of experience
  • Bachelor’s Degree in Engineering or related field
  • FDA Quality System Regulations
  • ISO 13485
  • Medical Device Directive

Work Rights

Not specified

Tailored Resume

Cover Letter