Senior Design Assurance Engineer

075

$120,450 - $176,660; not specified; not specified ...
Iso 14971 risk management
Fda quality system regulations
Iso 13485
Support new product development to ensure desired design performance meeting regulatory requirements and company policies

Job Summary

  • Support new product development to ensure desired design performance meeting regulatory requirements and company policies.
  • Lead Risk Management (ISO 14971) and Usability program activities, including planning, analyses (DFMEA, FTA, Risk/Benefit), and mitigations.
  • The total rewards program includes base salary, cash-based incentive, and comprehensive benefits with immediate eligibility, plus 401(k) matching.

Matching Summary

Support new product development to ensure desired design performance meeting regulatory requirements and company policies.

Salary

$120,450 - $176,660; Not specified; Not specified

Skills & Requirements

Must-have

  • ISO 14971 Risk Management
  • FDA Quality System Regulations
  • ISO 13485
  • Medical Device Directive
  • Design Controls
  • Supplier Controls
  • Process Validation

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
  • Master’s Degree preferred
  • Experience with FDA and European regulated medical devices preferred

Work Rights

Not specified

Tailored Resume

Cover Letter