Senior Design Assurance Engineer

Integer

$120,450 - $176,660 py
Medical device fda/european regulatory requirements
Quality management systems (qms)
Iso 14971 risk management
Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements and company policies

Job Summary

  • Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements and company policies.
  • Lead Risk Management and Usability program activities, including planning, analyses (DFMEA, FTA, Risk/Benefit), and mitigations.
  • Generate and/or review design verification and validation protocols and reports, and provide expert guidance to R&D.

Matching Summary

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

Salary

$120,450 - $176,660

Skills & Requirements

Must-have

  • Medical device FDA/European regulatory requirements
  • Quality Management Systems (QMS)
  • ISO 14971 Risk Management
  • Design Verification and Validation
  • Process Validation
  • Supplier Risk Management
  • Root Cause Analysis
  • CAPA preparation

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, Medical Device Directive
  • Proficiency in statistical methods (ANOVA, SPC, DOE)
  • Proficiency in quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter