Medical Device Product Manager

Exergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.

Our Temporal Scanner™ is the most efficacious, non-invasive thermometer ever created. Exergen holds over 100 issued and pending U.S. and foreign patents, and is the only manufacturer of retail medical thermometers in the U.S. Presently, half of hospitals and pediatricians currently use the Exergen Temporal Scanner, and well over 14 million consumers use one at home.

Founded by Harvard-research scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA.

Medical Device Product Manager

Reporting directly to the CEO, the Medical Device Product Manager will lead teams responsible for the overall execution of critical business programs from concept development through manufacturing transfer, commercialization and marketing.

This is a high visibility role, requiring decisive judgment and interaction with multiple internal and external teams. The program manager interfaces with all levels of management in fulfilling the planning, scheduling, organizing, directing, and controlling of the development program through the CEO. Works with senior managers of engineering, manufacturing, procurement, regulatory, and marketing to create cross-functional project team(s) to ensure all internal and external targets and objectives are completed effectively and in a timely manner. The ideal candidate is a technically capable, results-oriented leader with experience in successfully executing medical device product development and marketing programs.

Key Responsibilities and Activities:

· Leadership role responsible for managing product development programs.

· Lead and coach internal and external technical resources to support programs.

· Work collaboratively with product marketing, development, manufacturing, engineering, operations, regulatory affairs, clinical affairs, sustaining, product specialists and quality teams to execute programs on time and on budget.

· Build and implement program management tools and processes to effectively execute programs.

· Timely tracking and presentation of program status.

· Participates in the creation of the program objectives and overall project scope.

· Ensures that projects are managed within project timeline and budget baselines.

· Monitors and reports project status to the CEO.

· Works independently and with the project teams to develop, maintain, and align an accurate, integrated project timeline, and resource plan.

· Understands critical path activities, anticipates risks, and creates contingency plans in collaboration with project teams.

· Generates analysis of timeline, and resource information that facilitate scenario planning, contingency planning, risk assessment and management, problem solving, and decision making.

· Manages engagements with outside engineering partners as necessary to design, build, and test custom medical device systems, subsystems, and software.

Required Education and Experience:

· 8+ years of experience working in an FDA/ISO regulated medical device/medical equipment environment.

· 5+ years of experience preferred managing technical teams and programs.

· Detail oriented with strong organizational skills.

· Strong leadership and interpersonal skills.

· Strong program management skills with accountability for budgets, milestones, and deliverables.

· Excellent verbal and written communication skills.

· Effective analytical and decision-making skills.

· Must have a proven history of working in a fast-paced environment with a demonstrated ability to adjust to changing priorities.

· Understanding of regulatory procedures/standards.

· Ability to manage teams and individuals in a matrix environment, ability to track team performance against objectives, use of effective meeting management tools and techniques, and knowledge of decision-making and conflict resolution techniques.

· An Expert or Power User level project management related software/tools to facilitate:

o Scheduling

o Tracking project tasks and milestones o Resource utilization

o Management Reporting

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Education:

BS in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or equivalent is required. Marketing, or other formal training/experience, is essential.