Senior Sustaining Engineering Manager

BioTalent; Wilmington (MA); On-site; USD 150,000 - 230,000; Full time

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.

Skills

Leadership

Cross-functional leadership

Problem-solving

Effective communication

Education

Bachelor's degree in Engineering

Advanced degree in Engineering/Business

Tools

SolidWorks

Job description

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

Responsibilities

• Lead, mentor, and develop a team of sustaining engineers.
• Drive resolution of complex product, manufacturing, quality, and reliability challenges.
• Manage engineering changes, design modifications, supplier transitions, product remediation efforts, and obsolescence initiatives.
• Partner closely with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, R&D, and Commercial teams.
• Lead root cause investigations, corrective actions, and continuous improvement activities.
• Ensure compliance with design controls, quality systems, and applicable regulatory requirements.
• Support FDA, EU, and other international regulatory submissions and product changes.
• Oversee engineering documentation including drawings, specifications, bills of materials, and technical records.
• Drive product and process improvements to enhance quality, reliability, and operational efficiency.
• Serve as a senior technical resource for cross-functional teams and executive leadership.

Qualifications

• 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 experience managing products throughout the full lifecycle, including sustaining engineering.
• Strong knowledge of ISO 13485, FDA Quality System Regulations, EU MDR, and design controls.
• Experience with engineering change management, CAPA, nonconformances, complaint investigations, and risk management.
• Strong mechanical and manufacturing engineering background.
• Experience supporting FDA 510(k) submissions and CE Technical Documentation.
• Proficiency with SolidWorks or comparable CAD platforms.
• Excellent problem-solving, communication, and cross-functional leadership skills.

Preferred Experience

• Advanced degree in Engineering, Business, or a related technical 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 managing supplier transitions, obsolescence, cost reduction, and continuity-of-supply initiatives.
• Ability to balance strategic leadership with hands-on technical execution.

This is an excellent opportunity for an experienced engineering leader looking to influence product strategy, drive operational excellence, and lead a high-impact sustaining engineering function within a growing medical device organization.