R&D Project Manager - Medical Device/Reagents

Our client is a global provider of reagents and systems for diagnosing cancer. The company provides diagnostic technology and makes research equipment. Their products include equipment for flow cytometry, immunocytochemistry and microbiology products used to identify sexually transmitted diseases, stomach ulcers, and other ailments.



 

Summary:

Manages multidiscipline cross-functional product development teams from the conceptual design stage through product development, product transfer to manufacturing, product launch, and post-launch support.  Provides leadership and direction in the planning, organizing, and controlling of projects to achieve the defined time, cost, and performance objectives.

 

Duties and Responsibilities:

? Determines what has to be done (work scope), by when (schedule), and for how much (budget).  Accountable for project success.

? Develops and manages the Project Plan as well as establishes operational goals to meet strategic plans and objectives.

? Builds relationships within the project team and with functional department supervisors and executive level management.  Creates an environment in which individuals are highly motivated to work together as a project team and develops an environment of trust, high expectations and enjoyment.

? Coordinates and integrates activities across multiple, functional lines including Engineering, Manufacturing, Service, Quality, Regulatory, Marketing, and Finance.

? Establishes project schedules and tools to track actual progress vs. planned progress, analyzes the cost/schedule/performance impact, and intervenes and is proactive, resolving problems before they impact project goals.

 

Qualifications:

? Bachelor?s degree in a related scientific or engineering field

? 15+ years related experience.

? Experience in managing and launching complex Class 1 or Class 2 medical device projects requiring integration of several disciplines and functional areas.

? Experience with reagents

? Familiar with FDA QSR and ISO 9000 regulatory requirements.

? Project Management Professional (PMP) certification preferred.

? Up to 20% travel may be required.

? Knowledge of design controls and regulatory requirements associated with the development of complex medical diagnostic products.

? Experience with earned value metrics (EVM) and risk identification/mitigation.

 

Benefits:

Competitive Compensation, top of the line medical, dental and vision coverage, 401K with matching, 3 weeks vacation, 13 paid holidays 2 weeks sick time.