Manager, Sustaining Engineering

Terumo•Davie, FL

About The Position

The Manager, Sustaining Engineering position is responsible for the organizational development, functional management and performance of the Sustaining Engineering group with direct supervisory, development and performance planning responsibilities for the engineering and technical personnel within Sustaining Engineering group. The Manager, Sustaining Engineering will be accountable for managing post-release product changes relating to form, fit, function, or performance that relate to product requirements changes such as potentially affecting device usability, dimensional, material, or regulatory standards.

Requirements

Extensive experience in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements.
Demonstrated understanding of the cross-functional interactions needed for the development and change management of products within medical device industry design control guidelines
Effective communication skills, both verbal and written.
Ability to develop budgetary estimates and manage their execution.
Functional management and organizational development experience in managing an Engineering group and in preparing Performance and Development Plans and reviews.
SME understanding of design and verification and validation (V&V) approaches.
BS in Engineering or other related technical field with 7 years of Medical Device product development experience.
Demonstrated understanding of the roles and responsibilities of the cross-functional activities needed to successfully develop new and transfer existing products to manufacturing and release for commercialization.
Demonstrated ability to manage design changes and assess engineering V&V activities related to product form, fit, function, and performance

Responsibilities

Responsible for the organizational development, functional management and performance of the Sustaining Engineering group. This includes providing direct supervision, development and performance planning to engineering and technical personnel within the Sustaining Engineering group; prepare Performance Plans, Individual Development Plans (IDPs) and conduct mid- and full year Performance Reviews with associates.
Accountable for leading and driving change order activities related to product design changes, the team supporting the change, and schedule.
Accountable for ensuring existing products remain compliant to all new and existing standards.
Accountable for developing or hiring technical SME expertise in design control and product design changes.
Develop budgetary estimates and be responsible for the Sustaining Engineering departmental budget.
Prepare presentations and formally present project updates and reviews to senior management.
Performs other duties as assigned.