Senior Medical Device Sustaining Engineering Lead

BioTalent

Wilmington (MA)

On-site

USD 150,000 - 230,000

Full time

14 days+

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Job summary

BioTalent is seeking a Senior Sustaining Engineering Manager to provide strategic and technical leadership for an established product portfolio in a growing medical device company. You will lead sustaining engineering initiatives focused on reliability, quality, manufacturability, compliance, lifecycle management, and continuous improvement in a highly regulated environment.

You will manage a team of engineers, drive cross-functional collaboration, and ensure compliance with FDA/ISO design

Qualifications

Bachelor's degree in Engineering or related technical discipline required.
15+ years of engineering experience in a regulated manufacturing environment, preferably medical devices.
8+ years in engineering leadership and full lifecycle product experience.

Responsibilities

Lead and develop a team of sustaining engineers.
Drive resolution of complex product, manufacturing, quality, and reliability issues.
Manage engineering changes, design modifications, and obsolescence initiatives.
Collaborate with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, R&D and Commercial teams.
Lead root cause investigations and CAPA activities.
Ensure compliance with design controls and regulatory requirements (FDA/ISO).
Support regulatory submissions and technical documentation updates.
Oversee engineering documentation and records.