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Philips

Makes medical devices and personal health products

Senior Design Quality Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-time$103k - $145k /yr

About the Job

Requirements

  • Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
  • At least 2 years of experience in product design, demonstrated through a role in quality, engineering, service, or manufacturing in a regulated environment with medical device experience.
  • Expertise in applying risk management to medical devices (IEC 14971), medical device software life-cycle processes (IEC 62304), applying usability engineering to medical devices (IEC 62366), and 21 CFR 820 are pluses.
  • Must be able to perform the minimum physical, cognitive, and environmental job requirements with or without accommodation.
  • Must have U.S. work authorization; candidates who require sponsorship for a work-authorized visa now or in the future will not be considered.
  • Must reside in or within commuting distance of Bothell, Washington; Cambridge, Massachusetts; or Reedsville, Pennsylvania.

Responsibilities

  • Oversee system and hardware quality and safety risk management throughout the product life cycle.
  • Provide independent oversight of the design input process, design verification and validation activities, design transfer, product realization, and field performance to ensure design requirements are met.
  • Serve as the project team's single point of contact responsible for ensuring that hardware design meets quality and compliance standards at every milestone.
  • Perform independent technical assessments of product quality performance and post-market product quality analysis.

Desired Qualifications

  • Experience with Failure Mode and Effects Analyses (FMEAs) and Product Safety Risk Management is preferred.
  • At least 5 years of product design experience is preferred.

About the Company

Philips

Makes medical devices and personal health products

Philips makes medical equipment and software for hospitals and care providers, along with personal health products for consumers. Its hospital portfolio spans MRI and CT scanners, ultrasound, image-guided treatment systems and patient monitors, while Sonicare and Avent cover oral health and baby care. Clinical software connects medical images and patient data across care teams, and the company earns revenue from equipment, software, maintenance and consumer product sales. It works with health systems through long-term technology and service partnerships, including solutions for care at home. Founded in 1891, Philips is headquartered in Amsterdam, the Netherlands.

Company size
10,001+
Company stage
Acquired
Total funding
$164.7M
Headquarters
Andover, MN
Founded
1891

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