Demo

Senior Research And Development Engineer

Pragmatic
Bedford, MA Full Time
POSTED ON 3/11/2025
AVAILABLE BEFORE 4/9/2025

Senior/Principal Engineer

A leading medical device company is seeking a highly motivated Senior / Principal R&D Engineer to drive the development of next-generation hydrogel-based implantable medical devices. This role is ideal for an engineer who thrives in a hands-on lab environment and is eager to contribute to cutting-edge R&D initiatives in a fast-paced startup setting.


Why This Opportunity?

  • Work on Class III implantable medical devices that improve patient outcomes.
  • Lead and contribute to preclinical and biocompatibility testing (ISO 10993), design controls, and validation.
  • Opportunity to grow within the company while remaining focused on technical excellence.
  • Join a collaborative, high-growth environment with direct access to leadership and key decision-makers.


Key Responsibilities

  • Drive R&D projects, ensuring technical milestones align with company goals.
  • Execute design controls, FMEA, and verification/validation processes.
  • Conduct biocompatibility testing, preclinical studies, and sterilization validation.
  • Develop and implement testing strategies, process development, and regulatory documentation.
  • Collaborate with cross-functional teams, including manufacturing, quality, and regulatory affairs.
  • Engage in hands-on lab work, including prototype development and testing.
  • Provide technical mentorship and guidance to junior engineers.


Who We're Looking For

  • 5 years of experience in medical device development (3 with an MS degree).
  • Strong knowledge of design controls, FMEA, and verification/validation processes.
  • Experience with Class III implantable medical devices is a plus.
  • Background in preclinical testing, biocompatibility (ISO 10993), and regulatory compliance.
  • Ability to manage multiple projects and work independently.
  • Startup or fast-paced environment experience is highly desirable.
  • Strong technical writing skills for regulatory documentation and reporting.


Work Environment & Location

  • On-site role (4-5 days per week)—must be comfortable working in a hands-on lab setting.
  • Some flexibility on Fridays if lab work is completed.
  • Collaborative, high-growth environment with direct exposure to leadership.


Next Steps

If you're an experienced medical device engineer looking for an exciting opportunity to drive innovation and make a tangible impact, we’d love to hear from you!

Apply today or reach out to learn more!

Salary : $120,000 - $160,000

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