Sustaining Engineering Leader — Medical Devices

Terumo Aortic; Town of Florida (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Terumo Aortic is seeking a senior leader to head Sustaining Engineering, guiding organizational development and the delivery of post-release product changes with regulatory and quality compliance. The role includes managing a team, directing design-change activities, and maintaining product lifecycle integrity.

The incumbent will lead performance reviews, budget planning, and cross-functional collaboration to ensure robust design control and timely updates to senior management.

Qualifications

• Knowledge of global medical-device development per regulatory and quality standards.
• Understanding cross-functional interactions required for product development and change management under medical-device design-control guidelines.
• Subject-matter expertise in design and verification and validation approaches.
• Functional management and organizational-development capability for leading an engineering group.
• Ability to develop budgetary estimates and manage their execution.
• Effective written, verbal, technical, and presentation skills.
• Bachelor of Science degree in Engineering or another related technical field.
• Minimum of seven years of medical-device product-development experience.
• Demonstrated understanding of cross-functional roles for development and transfer to manufacturing.
• Ability to manage design changes and assess V&V activities related to product form, fit, function.

Responsibilities

• Lead the organizational development, functional management, and overall performance of the Sustaining Engineering group.
• Supervise and develop engineering and technical personnel; prepare performance plans and conduct reviews.
• Lead and drive change-order activities for product design changes with coordination of teams and schedules.
• Ensure existing products remain compliant with quality, regulatory, and technical standards.
• Develop internal technical subject-matter expertise in design-control and product design changes.
• Develop budgetary estimates and manage the department budget and execution.
• Prepare and present project updates and reviews to senior management.
• Follow EH&S and Quality System policies, including product and patient safety.

Skills

Regulatory knowledge

Cross-functional coordination

Design verification & validation

Staffing & development

Budget management

Communication skills

Leadership

Education

Bachelor of Science in Engineering

Job description

Terumo Aortic is seeking a senior leader to head Sustaining Engineering, guiding organizational development and the delivery of post-release product changes with regulatory and quality compliance. The role includes managing a team, directing design-change activities, and maintaining product lifecycle integrity.

The incumbent will lead performance reviews, budget planning, and cross-functional collaboration to ensure robust design control and timely updates to senior management.