Job Overview
This is a pivotal role in the development and commercialization of groundbreaking healthcare technologies. The successful candidate will be responsible for leading cross-functional engineering teams through the full product lifecycle.
* Develop and implement system-level design strategies for new and existing products.
* Evaluate stakeholder needs to create clear, traceable system requirements.
* Coordinate integration and testing activities across disciplines.
* Provide technical direction and mentorship to engineers across various functions.
* Maintain and develop design control documentation, SOPs, and requirements using tools like DOORS or Modern Requirements.
* Manage change control and configuration management processes.
* Support regulatory submissions in partnership with Quality and Regulatory teams.
* Conduct risk assessments, including dFMEA and hazard analysis.
* Collaborate closely with Quality, Manufacturing, Marketing, and Regulatory teams to ensure smooth development and launch.
Key responsibilities include driving system-level design, evaluating stakeholder needs, coordinating integration and testing, providing technical direction and mentorship, maintaining and developing design control documentation, managing change control and configuration management, supporting regulatory submissions, conducting risk assessments, and collaborating closely with other teams.
Requirements include 5+ years in product development, preferably in medical devices, a strong background in systems engineering, a proven track record of leading technical teams through phase-gate processes, skills in writing SOPs, guidance docs, and technical documentation, experience in regulatory environments (FDA QSR), high proficiency in Microsoft Excel (incl. macros) and Microsoft Project, familiarity with tools such as DOORS, SolidWorks, MATLAB, LabVIEW, Minitab, and strong communication and leadership skills.