Senior Design Assurance Engineer

163

Base: $120,450 - $176,660; bonus/equity: cash-base...
Quality management systems (qms)
Iso 14971 risk management
Design controls
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 review design verification, design validation, and process validation protocols and reports, providing expert guidance to cross-functional teams.

Matching Summary

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

Salary

Base: $120,450 - $176,660; Bonus/Equity: cash-based incentive program; Benefits: comprehensive benefits package with immediate eligibility

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • ISO 14971 Risk Management
  • Design controls
  • Supplier controls
  • FDA regulations
  • ISO 13485
  • Medical Device Directive

Nice-to-have

  • Customer success focus
  • Collaborative team environment
  • Respectful interactions
  • Open and honest communication
  • Lean sigma tools proficiency

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 7-10 years of experience
  • Master's Degree preferred
  • Experience interpreting design schematics and drawings
  • Proficiency in statistical methods (ANOVA, SPC, DOE)
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

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