Senior R&D Tech Lead, Medical Devices

Microline Surgical

Beverly (MA)

On-site

USD 140,000 - 190,000

Full time

5 days ago

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Job summary

Microline Surgical is seeking a Senior Tech-Lead in Beverly, MA to steer cross‑functional teams in designing and developing new medical devices, reducing cost and lead times while meeting market needs. You will drive technology and component strategies, translate customer needs into requirements, mentor engineers, and ensure design control per ISO and FDA guidelines, DHF deliverables, and robust testing.

This role requires 6–10 years in medical device R&D and at least 3 years of technical

Qualifications

BS or MS in Mechanical or Biomedical Engineering.
6–10 years in the medical device industry, developing Class II devices.
Minimum 3 years of Technical Management or Project Leadership.
Knowledge of ISO, FDA, GMP and design control processes.
Experience translating customer needs to product requirements and DHF deliverables.
Strong interaction with physicians and hands-on lab capability.
Proficient in SolidWorks; knowledge of DFA.

Responsibilities

Translates customer needs into product requirements and design specifications.
Leads cross‑functional teams to develop new devices and improve existing products.
Designs, analyzes, and documents product designs in compliance with ISO and FDA guidelines.
Coordinates from prototype to pilot manufacturing, including process validation.
Mentors engineers and represents R&D in conferences and meetings.
Maintains design history files and prepares complex engineering reports.