Sustaining Engineering Manager

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

Leads the organizational development, functional management, and performance of the Sustaining Engineering group, including direct supervision and development of engineering and technical personnel. Manages post-release product changes affecting form, fit, function, performance, usability, dimensions, materials, or regulatory standards.

Main Responsibilities

% of Role

Lead the organizational development, functional management, and overall performance of the Sustaining Engineering group.

20%

Supervise and develop engineering and technical personnel; prepare performance plans and Individual Development Plans and conduct mid-year and full-year performance reviews.

20%

Lead and drive change-order activities for product design changes, including team coordination, schedules, and changes affecting product form, fit, function, or performance.

20%

Ensure existing products remain compliant with applicable new and existing quality, regulatory, and technical standards.

15%

Develop internal technical subject-matter expertise or recruit needed expertise in design control and product design changes.

10%

Develop budgetary estimates and manage the Sustaining Engineering departmental budget and its execution.

10%

Prepare and formally present project updates and reviews to senior management and perform other assigned duties.

5%

Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Organizational Impact:

Accountable for the continued compliance, performance, and lifecycle management of released medical devices. Decisions affect product quality, regulatory compliance, change-order execution, departmental capability, schedules, and budget performance.

Communication & Influence:

Leads engineering and technical associates and coordinates cross-functional activities required to manage product changes. Communicates project status, technical assessments, resource needs, risks, and recommendations and formally presents reviews to senior management.

Manages post-release product changes that may affect usability, dimensions, materials, regulatory standards, and product form, fit, function, or performance. Applies design-control, verification and validation, regulatory, technical, resource, and budget judgment to determine appropriate actions.

Leadership & Autonomy:

Directly manages the Sustaining Engineering group and is responsible for staffing, organizational development, performance planning, associate development, and departmental results. Exercises managerial autonomy within company procedures and escalates significant product, regulatory, schedule, resource, or budget risks.

Office Location

Sunrise, FL

Direct Reports (#): 6

Indirect Reports (#):

4

Organizational Chart:

Reports to Sr. Manager/Director, Engineering. Direct and indirect report counts were not provided in the source job description and are to be confirmed.

Position Requirements:

Knowledge, Skills and Abilities (KSAs):

• Knowledge of global medical-device development in accordance with applicable global regulatory and quality standards and requirements.
• Demonstrated understanding of 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 the cross-functional roles and responsibilities needed to develop new products and transfer existing products to manufacturing and commercialization.
• Demonstrated ability to manage design changes and assess engineering verification and validation activities related to product form, fit, function, and performance.