Senior Medical Device Sustaining & Reliability Leader

BioTalent; Wilmington (MA); On-site; USD 170,000 - 220,000; Full time

Job summary

BioTalent is seeking a Senior Sustaining Engineering Manager to lead a team responsible for an established medical device portfolio. You will drive product reliability, quality, and lifecycle management while partnering across Quality, Regulatory, Operations, and Supply Chain.

This leadership role focuses on solving complex technical challenges, developing high-performing teams, and influencing long-term success in a regulated environment with direct impact on commercialized products.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 15+ years of engineering experience within a regulated manufacturing environment (medical devices preferred).
• 8+ years of engineering leadership experience.
• Strong knowledge of regulatory standards, design controls, and CAPA processes.
• Proficiency with SolidWorks or comparable CAD platforms.

Responsibilities

• Lead, mentor, and develop a team of sustaining engineers supporting an established medical device portfolio.
• Drive resolution of complex product, manufacturing, supplier, quality, and reliability challenges.
• Lead engineering changes, product improvements, supplier transitions, remediation efforts, and obsolescence initiatives.
• Partner with Quality, Regulatory, Operations, Manufacturing, Supply Chain, R&D, and Commercial teams for product lifecycle management.
• Lead root-cause investigations, CAPAs, risk assessments, and continuous improvement activities.
• Ensure compliance with design controls, FDA regulations, and global regulatory requirements.
• Support regulatory submissions, technical documentation updates, and product change activities.
• Drive initiatives to improve product quality, reliability, manufacturability, and operational efficiency.

Skills

Team leadership

Regulated manufacturing

Sustaining engineering

Quality systems

Product lifecycle

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Job description

BioTalent is seeking a Senior Sustaining Engineering Manager to lead a team responsible for an established medical device portfolio. You will drive product reliability, quality, and lifecycle management while partnering across Quality, Regulatory, Operations, and Supply Chain.

This leadership role focuses on solving complex technical challenges, developing high-performing teams, and influencing long-term success in a regulated environment with direct impact on commercialized products.