PROGRAM MANAGER—MEDICAL DEVICE

The Challenge:

As an industry leader in the design, development, and manufacturer of leading edge medical devices our client has immediate needs for a talented Program Manager.  This key individual will be directly responsible for leading high visibility of complex projects and programs of disposable medical devices--from the planning/ administration of the product through all development phases.   This will require significant Project Management capabilities –leading cross functional teams and coordination of: new project definition and scope, and take project from developmental stage to product release. Additionally responsibilities will likely include: 

• Reviews product design, tooling components and automation requirements for compliance with engineering principles, company standards and customer requirements.  Coordinates activities concerned with technical development, scheduling and resolving engineering design and test problems
  
• Leads multi-functional product development teams by coordinating/delegating technical and administrative responsibilities, identifying critical action items and obtaining closure, and following corporate product development guidelines
  
• Coordinates and works with team leaders and team members to ensure pipeline initiatives are satisfied. Matrix responsibility for core team members and support team members
  
• Provides guidance, advice, and support to Engineers and Technicians in areas of:  project leadership, technical consultation, documentation, quality, GMP procedures, Engineering disciplines, interfaces with other functions, and company policy.
  
• Develops laboratory tests and protocols to assure conformance of prototype devices to performance specifications, FDA regulatory and biocompatibility requirements.
  
• Evaluates device performance through animal and/or human clinical investigation; and, as required, implements appropriate product changes to include revision of performance specifications.
  
• Serves as mentor and coach to Team Leaders, Engineers, and Technicians to thrive in a results-driven environment.  Implements performance management duties.

The Requirements:

• BS/MS in engineering with 10-15 years of product development engineering experience. 
  
• 5-10 yr track of significant development activity within the disposable medical device field.
  
• Well versed in Project Management of cross-functional/ matrix teams.
  
• Well grounded in engineering principles and practices-- design reviews and development of engineered projects (MS Project).
  
• Prior experience with the guidance / supervision / and development of younger engineers.
  
• Must have the ability to work effective in a team based environment –with a “costumer appreciation” perspective.

*** CANDIDATES MUST HAVE MEDICAL DEVICE EXPERIENCE**