Senior Sustaining Engineering Manager

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

Our client, a growing medical device manufacturer, is seeking a Senior Sustaining Engineering Manager to lead a team responsible for an established product portfolio. This individual will play a key role in driving product reliability, quality, manufacturing performance, lifecycle management, and continuous improvement while partnering closely with leaders across Engineering, Quality, Regulatory, Operations, and Supply Chain.

This is a highly visible leadership opportunity for someone who enjoys solving complex technical challenges, developing high-performing teams, and influencing the long-term success of commercialized products in a regulated environment.

Key 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 closely with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, R&D, and Commercial teams to support product lifecycle management.
• Lead root cause investigations, CAPAs, risk assessments, and continuous improvement activities.
• Ensure compliance with design controls, quality systems, FDA regulations, and global regulatory requirements.
• Support regulatory submissions, technical documentation updates, and product change activities.
• Drive initiatives that improve product quality, reliability, manufacturability, and operational efficiency.

What We're Looking For

• Bachelor's degree in Engineering or a related technical discipline.
• 15+ years of engineering experience within a regulated manufacturing environment, preferably medical devices.
• 8+ years of engineering leadership experience.
• Demonstrated success supporting products throughout the full lifecycle, including sustaining engineering activities.
• Strong knowledge of ISO 13485, FDA Quality System Regulations, EU MDR, and Design Controls.
• Experience with engineering change management, CAPA, complaint investigations, nonconformances, and risk management.
• Strong mechanical and manufacturing engineering foundation.
• Experience supporting regulatory submissions and technical documentation updates.
• Proficiency with SolidWorks or comparable CAD platforms.
• Excellent communication, collaboration, and team leadership skills.

Preferred Experience

• Advanced degree in Engineering, Business, or a related field.
• Leadership experience supporting a diverse medical device product portfolio.
• Experience with disposable devices, precision-engineered products, or needle-based technologies.
• Background in product reliability, Design for Manufacturability (DFM), Lean, Six Sigma, or related methodologies.
• Experience leading supplier transitions, continuity-of-supply initiatives, cost reduction programs, and obsolescence management.
• Ability to balance strategic leadership with hands-on technical problem solving.

Why Join?

• Lead a highly visible function with broad influence across Engineering, Operations, Quality, and Regulatory.
• Shape strategy and decision-making for an established medical device product portfolio.
• Join a growing organization investing in its products, people, and operational capabilities.
• Manage a blend of strategic initiatives and hands-on technical challenges.
• Opportunity to develop team capabilities, drive operational excellence, and make a measurable impact on business performance.