Senior Design Assurance Engineer

154

$120,450 - $176,660; not specified; not specified ...
Iso 14971 risk management
Design verification and validation
Fda quality system regulations
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 and Usability program activities, including planning, analyses (DFMEA, FTA, Risk/Benefit), and mitigations.
  • Provide expert guidance in design controls, supplier controls, test requirements, and product development manufacturing engineering.

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
  • Design Verification and Validation
  • FDA Quality System Regulations
  • ISO 13485
  • Medical Device Directive
  • Statistical Methods (ANOVA, SPC, DOE)
  • Lean Sigma Tools (RCA, QFD)

Nice-to-have

  • Collaboration and conflict resolution
  • Coaching and team leadership
  • Cross-functional team guidance
  • Supplier risk management initiatives

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

Work Rights

Not specified

Tailored Resume

Cover Letter