Principal Design Quality Engineer

Fresenius Medical Care

Base: $117,000 - $196,000 annual rate; bonus/equit...
8-12 years of design control experience
Fda and iso regulatory compliance knowledge
Risk management and test method validation expertise
The role requires a seasoned professional to ensure New Product Development projects comply with FDA and ISO requirements through rigorous design control processes

Job Summary

  • The role requires a seasoned professional to ensure New Product Development projects comply with FDA and ISO requirements through rigorous design control processes.
  • Responsibilities include acting as a subject matter expert on Risk Management, Test Method Validation, and Reliability Engineering while guiding engineering staff.
  • The position offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) match, and potential performance-based bonuses.

Matching Summary

The role requires a seasoned professional to ensure New Product Development projects comply with FDA and ISO requirements through rigorous design control processes.

Salary

Base: $117,000 - $196,000 annual rate; Bonus/Equity: Potential for performance-based bonuses; Benefits: Medical, dental, vision, 401(k) match, paid time off, parental leave

Skills & Requirements

Must-have

  • 8-12 years of design control experience
  • FDA and ISO regulatory compliance knowledge
  • Risk Management and Test Method Validation expertise

Nice-to-have

  • Advanced degree in engineering or related field
  • Mentorship capabilities for junior staff
  • Experience with multiple technologies and sites

Key Requirements

  • Bachelor's degree required; Master's preferred
  • 8+ years of experience with Bachelor's or 6+ with Master's
  • Deep understanding of Design History File (DHF) elements

Work Rights

Not specified

Tailored Resume

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