Senior Design Assurance Engineer

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$120,450 - $176,660; not specified; comprehensive ...
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, and mitigations, maintaining the risk management file for the life of the device.
  • Provide expert guidance in the review of technical documentation, test criteria, test methods, and process validation protocols for successful product transfer to production.

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; Not specified; Comprehensive benefits package including medical, dental, vision, 401(k) with match, PTO, holidays

Skills & Requirements

Must-have

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

Nice-to-have

  • GB Core Beliefs adherence
  • Lean Sigma tools proficiency
  • Collaboration and coaching skills
  • Cross-functional team leadership

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 utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter