Role details

Design Quality Engineer - Medical Device

Marlborough   •   USD60,000 - USD90,000   •  Permanent

Bullet points

  • Medical Device Engineer position with a NASDAQ-listed company in Marlborough.
  • A terrific opportunity to become a part of a global medical device manufacturer!

About Our Client

The Design Quality Engineer- Medical Device position located in the Marlborough area is with a publicly-held medical device manufacturer. This organization manufactures a range of surgical, diagnostic and other medical devices used by hospital and healthcare providers throughout the globe.

Job Description

The Design Quality Engineer- Medical Device will:

  • Provide design assurance support in design and development of medical device products, and facilitate the application of design controls and risk management.
  • Implement and lead all product risk management activities.
  • Key developer, advisor and reviewer of validation methods and protocols, test methods, statistical analysis methods, and specification derivation and assignment.
  • Key contributor to development and validation plans and processes.
  • Establish, communicate, and control risks for risk management reporting.
  • Review new and modified product designs for complex electromechanical medical devices that include software and sterile, single-use disposables for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility and conformance to product requirements.
  • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.

The Successful Applicant

The Design Quality Engineer - Medical Device must have:

  • Bachelor of Science in Engineering is required
  • Minimum 1-5 years of quality engineering experience in a permanent position with a FDA registered medical device company.
  • Must be local; no relocation assistance is issued.
  • Strong Product validation and design experience

What's on Offer

Offer:

  • Excellent base salary for a mid-level position.
  • 10% Bonus
  • Great opportunity for exposure with a large medical device manufacturer
  • Strong benefits package

Apply for this job

Click the Apply or LinkedIn button below or contact Daniel Ferzoco quoting job reference 1196452
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