Engineering Project Manager

Senior Program Manager

Seeking a Senior Program Manager to lead released product Medical Device projects. Projects may include both design and manufacturing-focused changes, including: manufacturing site transfers, capacity expansion, MDR compliance, product design enhancements, and management of supplier-requested process changes. The individual for this role should have capability and confidence to lead cross-functional teams which may include but is not limited to: mechanical/electrical design, software, quality/reliability, verification/validation, human factors, systems engineering, process development, supplier quality, sourcing, and regulatory affairs. The ideal candidate has 5+ years leading programs of a similar nature within a highly regulated field, medical device preferred.

Position Responsibilities:

• Plans, directs and implements all aspects of the company's design and development of medical device products or software systems.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Required Knowledge and Experience: Requires broad management knowledge and experience to lead project teams in one department. Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function. Requires a Bachelor’s degree and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.