Opportunity to join a highly successful leader and developer of devices that deliver critical therapy to patients in hospital and home care settings. The experienced engineering leader in this role will provide technical expertise and manage projects involving conceptual design, and pragmatic implementation and integration of electrical, software, mechanical, and disposables components.
- Lead cross functional teams in the refinement and development of capital medical equipment.
- Coordinate and prioritize engineering activities required to support the product life cycle.
- Solve significant technical challenges by employing structured problem solving.
- Define product requirements.
- Lead the hardware/software architecture concept definition for appropriate technologies and implementations that are selected.
- Develop project schedules and budgets to support programs.
- The planning, definition, and documentation of systems verification and validation activities.
- Expert and technical lead on Electromechanical Engineering issues, including IEC compliance.
- Ensure document management and design control compliance.
- Manage and communicate with external design firms.
- Conduct and manage structured design reviews.
- Write design requirements and specifications.
- Continue to build on Company Intellectual Property portfolio.
- Present program status to the Senior Leadership team.
- Interact with other department leaders to address and resolve cross functional challenges and issues.
- Ensure device adherence to industry Standards.
- BS or MS in Electrical Engineering, Biomedical Engineering, or Equivalent.
- 10 plus years’ experience in a Medical Device company managing development of capital equipment and the engineering resources, projects, budgets, and teams that enable successful commercialization of complex systems.
- Progressive responsibilities including managing internal resources, contract design firms, and test houses for compliance testing.
- Background working in an FDA QSR compliant and/or ISO 13485 certified environment.
- Strong technical leadership, verbal and written communication skills.