Senior Design Assurance Engineer

2kilo

Base: $120,450 - $176,660; bonus/equity: cash-base...
Medical device fda/european regulatory requirements
Iso 14971 risk management
Design verification and validation
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.
  • The company offers a comprehensive benefits package with immediate eligibility, including medical, dental, vision, and a 401(k) plan with company matching.

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

Skills & Requirements

Must-have

  • Medical device FDA/European regulatory requirements
  • ISO 14971 Risk Management
  • Design verification and validation
  • Process validation protocols
  • Supplier risk management

Nice-to-have

  • GB Core Beliefs
  • Lean Sigma tools
  • Collaboration and coaching

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

Work Rights

Not specified

Tailored Resume

Cover Letter