Our client is an award-winning product development firm who focuses on bringing medical devices from first concept to market launch. We are looking for a Program Manager who will be able to manage and execute the firms program direction in accordance with the client and development team goals.
- Develop and Maintain schedule, ensure schedule has been reviewed by internal supervisor. Schedule will include resource needs to accomplish tasks. Schedule and resource needs to be submitted to VPPM & VPSO at the beginning of the phase and updated on a monthly basis.
- Submit signed proposal and/or PO with program budget breakdown to accounting and business development by accurately completing the project setup sheet at the beginning of each phase.
- Ensure that any out of scope work is approved by either the client and/or internally. Ensure that additional project codes are utilized to track changes. Ensure that each PO has a separate job code.
- Ensure that the appropriate filing structure in the WIP/ Smarteam, CTS, etc. is setup.
- Ability to organize and communicate high-level presentations to clients, clinicians, and participating teams, as necessary.
- Develop with team, appropriate presentations of activities during each phase of program. Ensure that each presentation is reviewed internally by senior management prior to submitting to client/other.
- Demonstrated ability to direct and manage resources, make decisions, solve problem, exercise good judgment & flexibility and maintain budgets and schedule.
- Coordinate all aspects of program activities, between the client and firm industrial design, engineering, quality, regulatory, testing, documentation, etc.
- 5+ years of experience in consumer product development and/or medical equipment and device development
- Familiarity with appropriate FDA, QSR, and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge
- Experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, sheet metal fabrication, etc.
- Understanding of Industrial Design & research activities and their interface with engineering
- Understanding of Mechanical engineering development process utilizing 3D CAD or related engineering software techniques