Product Development Leader

4 days ago

Singapore beBeeEngineering Full time $90,000 - $120,000
Senior Medical Device Engineer Role Overview

Our organization is seeking a Senior Medical Device Engineer to play a vital role in the development of innovative medical devices. As a key member of our team, you will be responsible for working on early-stage product development, testing stages of product validation, and serving as a link between engineering teams and external key opinion leaders.

  • Key Responsibilities:
  • Understanding clinical needs from end-users and translating them into technical requirements.
  • Providing feedback from end-users and offering insights on the clinical workflow use of products.
  • Designing and running benchtop ex vivo and preclinical feasibility studies.
  • Analyzing feasibility study findings and writing reports for regulatory documentation filing.
  • Assisting in drafting risk management documents such as Design FMEA and Assembly FMEA.
  • Participating in project design review meetings.
  • Liaising with CROs and hospital partners to plan and perform product clinical studies.
  • Assisting in drafting contractual agreements with partners.
  • Staying up-to-date with medical device trends, clinical trials, and publications to provide clear-sighted improvements and inputs to our product portfolio.
  • Overseeing local and international awards and grants submissions.

Requirements and Qualifications:

To succeed in this role, you should possess the following qualifications and experience:

  • A Master's degree in Engineering or Science.
  • At least 3 years' experience in a clinical or human factor engineering role in the medical device industry.
  • Familiarity with the medical device design control process.
  • Understanding of IEC 62366, IEC , and USFDA human factor and usability engineering guidance documents.
  • Excellent communication and interpersonal skills.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced engineer looking for a new challenge, we would love to hear from you.

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