Senior Medical Device Engineer

3 weeks ago


Irvine, California, United States Nihon Kohden Full time
Senior Medical Device Engineer

We have an exciting opportunity for a Sr Medical Device Engineer to join our team at Nihon Kohden America. This role offers a competitive salary range of $108,000 to $145,000 based on experience and location.

Job Responsibilities
  • Conduct all engineering activities in compliance with FDA Regulations, ISO 13485, and other national and international quality and regulatory requirements and standards.
  • Establish quality assurance, engineering programs, and initiatives to ensure products are developed and manufactured according to applicable requirements, including ISO 60601-1.

This position requires strong technical expertise in design verification and validation, process validation, test method validation, and risk management activities throughout the medical device life cycle. You will collaborate with cross-functional teams to ensure seamless project execution and high-quality outcomes.

Qualifications
  • Bachelor's degree in electrical engineering or related discipline
  • 5+ years of experience in Medical Device Electrical Engineering and/or Quality Engineering
  • Certified Quality Engineer (CQE) preferred
Perks and Benefits

Nihon Kohden America provides a supportive work environment with opportunities for growth and development. Our benefits package includes health insurance, retirement plan, and paid time off, as well as access to training and education programs.



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