Genomic Health is seeking a highly talented and motivated Sr. Program Manager to join our Program Management Office. The primary responsibility will be to lead the workstream(s) for our complex IVD program. This person will work with the sub-team to develop and execute on plan. This project will involve both internal development and partnerships with external collaborators.
This individual must have a strong working knowledge of IVD and design control and be able to communicate with all levels in the organization. The successful candidate must be able to work both independently and in a collaborative environment, handle multiple projects in parallel.
RESPONSIBILITIES / DUTIES:
• Partner with workstream lead(s) to develop plans and execute on sub-team/team deliverables to meet project/program goals
• Lead sub-team meetings, create meeting minutes and follow up on action items
• Ensure effective communications with other sub-teams
• Ensure timely team completion of documents required for design reviews and design history file
• Drive open communication and cooperation with internal and external team members and stakeholders
• Identify and resolve or escalate project issues.
• Participate in advancing program management team functional abilities, including sharing best practices and methods/tools improvement initiatives.
• Define resource needs over the course of the project
• Other responsibilities as assigned.
QUALIFICATIONS:• BS/BA in Science or Engineering or a related discipline at a minimum
• Requires 12 years of experience in product development in the medical device industry, including 5 years of project management experience. IVD experience is desired, PMP is a plus.
• Working knowledge of 21CFR820, ISO 13485, ISO14971 is a must, CLIA regulations are desired
• Experience leading teams in product development of medical devices and identifying risks and mitigation plans
• Experience leading teams for product launch, a plus
• Demonstrated ability to work successfully in a cross-functional team environment
• Possess excellent communication skills
• Strong project management skills, including planning, prioritizing and organizing work, tracking budgets and meeting deadlines
• Strong PC skills including proficiency with Microsoft Project, PowerPoint, and Excel
• Experience preparing and making presentations to executive-level management and able to effectively adjust to technical and non-technical audiences
• Ability to motivate teams, resolve conflict and utilize influence to accomplish project goals