Senior Medical Device Program/Project Manager

Do you like making a long- term impact on improved medical care? You would here! Great opportunity to manage the development and commercialization of innovative medical devices, with resources from all quarters of a company with an expanding portfolio of products for treating cancer, cardiovascular, and organ failure. PMs at this dynamic organization are empowered and responsible for advancing products from early development through to the market. In practice, this means fruitful and ongoing interaction with all the functional areas that create successful products: R&D, QA, RA, Finance, Operations, Marketing, Clinical, Sales, Supply Chain, and Business Development.

Responsibilities:

  • Lead cross functional, multi-site teams in a collaborative environment to complete complex projects.
  • Establish and implement planning, timeline, budgeting, and reporting tools.
  • Lead team(s) through the project planning processes to predict timelines and establish critical paths, and track and report on progress to plan.
  • Work with team members to pro-actively identify and reduce risks, and communicate regularly with management to eliminate “surprises” and resolve potential issues.
  • Identify, recommend and implement best PM practices to improve the product development process.
  • Mentor project management team members to assist in developing their project management skills.
  • Work with appropriate players to ensure that projects adhere to quality and regulatory requirements.
  • Drive activities to support the design control process and ensure teams are prepared for phase reviews.
  • Coordinate support and guidance to the Clinical Affairs team for clinical trials, MD evaluations, and animal studies to test product designs.
  • Review legal contracts from project perspective for applicability to project milestones, etc.
  • Help develop and implement ongoing improvements of new business processes.
  • Travel regionally (to 15%) to support your product development projects.

Qualifications, Skills, and Knowledge:

  • A BS or greater in a technical field; PMP Certification and an MBA are pluses.
  • 6-15 years of demonstrated experience in medical device project or program management.
  • Successful experience leading multi-disciplinary teams developing complex medical devices in cross-functional environments.
  • Ability to rise to the task and thrive in a fast-paced, growing company .
  • Demonstrated ability to influence and improve the product development process, across levels and disciplines.
  • Broad understanding of the development process in the context of business goals and environment.
  • Strong organizational skills, and proficiency with common Microsoft tools such as Project and Excel.
  • Clear and succinct communication skills, both written and verbal.
  • Ability to effectively relate to and communicate at all levels of the organization, and externally.
  • Comfortable and confident interacting with, and presenting to senior managers.