You must live in the USA and have US Citizenship or a Green Card.
As one of the key members of the Engineering department, the Project Manager will, with general supervision from the Engineering Manager, own and lead projects from solicitation and proposal through design transfer for medical device components.
The Project Manager will lead the development of complex new products.
Manages all aspects of the project as required. (timelines, prototypes, testing, suppliers)
Leads cross-functional project teams to support design and development.
Communicates and works with manufacturing to ensure design manufacturability.
Meets with and works closely with the engineering team and customer to ensure all requirements are defined and met.
Researches, specifies and makes recommendations for materials and/or alternative solutions that meet project requirements.
Specifies and coordinates all prototype requirements and applicable testing through appropriate sources, either internal or external.
Generates appropriate documentation as required per Design Control Procedures.
Insures compliance with ISO, FDA and other applicable regulations.
Travel for but not limited to: training, departmental planning session, customer support.
EDUCATION / EXPERIENCE:
Bachelor’s degree in Engineering required (Mechanical Engineering or Biomedical Engineering is preferred)
3 or more years of experience in product development within medical device
Prior knowledge and experience in manufacturing processes of metals and plastics preferred.
Experience in a regulated industry (medical, military, aerospace, automotive, truck, etc...)
Understanding of geometric dimensioning and tolerance (GD&T) requirements for application to design projects.
Knowledge of various metal and polymer materials as well as testing specifications preferred.
3D CAD modeling experience required (UniGraphics or SolidWorks preferred) along with Microsoft Office 2010 Suite or newer (particularly Excel application).