What are the responsibilities and job description for the Senior Sustaining Engineering Manager position at BioTalent?
Senior Sustaining Engineering Manager
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.
For confidential consideration, please apply directly or contact me for additional details.