Senior Design Assurance Engineer

724842

$120,450 - $176,660; not specified; not specified ...
Medical device regulatory requirements
Iso 14971 risk management
Design controls and verification
Support new product development to ensure desired design performance meets medical device regulatory requirements and company policies

Job Summary

  • Support new product development to ensure desired design performance meets medical device regulatory requirements and company policies.
  • Lead Risk Management and Usability program activities, including planning, analyses (DFMEA, FTA, Risk/Benefit), and mitigations.
  • Provide expert guidance on design verification, validation, and process validation protocols and reports, and support supplier qualification.

Matching Summary

Support new product development to ensure desired design performance meets medical device regulatory requirements and company policies.

Salary

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

Skills & Requirements

Must-have

  • Medical device regulatory requirements
  • ISO 14971 Risk Management
  • Design controls and verification
  • Supplier risk management
  • Root cause analysis investigations

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
  • Practical knowledge of FDA QSR, ISO 13485, MDD
  • Proficiency in statistical methods
  • Proficiency in quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter