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Senior Program Manager, Product Development, IVD

Apply Share Job ID 1641 Category Program/Project Management Job Location Redwood City, California Posted Date 02/21/2020

Overview:

Genomic Health,a subsidiary of Exact Sciences is seeking a Sr. Program Manager with demonstrated interest, aptitude, and experience with IVD products to join our Product Development Program Management Team. The primary responsibility of this role will be to lead sub-teams within our complex IVD products and programs which include systems, assays, reagents, instruments, and software. This person will work with the team to develop and execute program plans within cost and schedule constraints. Assigned projects may involve both internal development, partnerships with external collaborators or 3rd parties, and interaction with various regulatory bodies.

This individual must have a strong working knowledge of IVD, design control, relevant regulations and be able to communicate with all levels in the organization. The successful candidate must be able to work independently, in a collaborative environment, and be able to handle multiple projects in parallel. The initial focus for this role will be preparation for and transition of existing products to comply with the European Union In Vitro Diagnostic Regulation (IVDR), evolving into an expert who can efficiently usher new pipeline products through the design and development process.

RESPONSIBILITIES / DUTIES:

· Partners with the cross-functional team to develop plans and execute on deliverables to meet project/program goals
· Manages the creation of the project work breakdown structure (WBS); works with teams to identify urgent/important functionality; sets priorities; manages work estimations; measures team progress; and negotiates team commitments.
· Performs program management for cross-functional teams responsible for the development, production, enhancement, or on market support of medical device products that satisfy customer, regulatory, and internal requirements.
· Identifies, tracks, and manages dependencies and handoffs to and from functional groups.
· Resolves program gaps, potential bottlenecks or delays and challenges assumptions.
· Lead sub-team meetings, set agendas, generate meeting minutes and follows up on action items
· Quickly grasps project and program goals and develops an overall strategy; clearly conveys these to the broader team to provide simplicity and focus.
· Ensure a clear definition of and timely completion of deliverables required for design reviews and the design history file
· Drive open communication and cooperation with internal and external team members and stakeholders
· Proactively identify and resolve or escalate project issues.
· Participate in advancing program management team functional abilities, including sharing best practices and methods/tools improvement initiatives.
· Collaborate with the team to define resource needs over the course of the project (labor, services, materials)
· Strives to simplify/streamline concepts and approaches for broader team consumption

QUALIFICATIONS:

· BS/BA in Science or Engineering or a related discipline at a minimum
· Requires 8 years of experience in product development in the medical device industry, including 3 years of project management experience. Previous IVD experience is required.
· PMP and/or scrum master certification is a plus
· Working knowledge of 21CFR820, ISO-13485, ISO-14971, CLIA regulations, IVDD, and IVDR
· Experience leading teams in product development of medical devices and identifying risks and mitigation plans
· Candidate should be self-motivated and able to work with minimal supervision, consistently take the initiative to get things done and do things before being asked by others or being forced to by events.
· Demonstrated ability to work successfully in a cross-functional team environment
· Possess excellent communication skills, both written and verbal. Ability to communicate with a broad audience of technical and non-technical staff including executive team members
· 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
· Ability to motivate teams, resolve conflict and utilize influence to accomplish project goals
· Experience with and understanding of systems engineering and the V-Model highly desired
· Previous experience with CAP/CLIA LDTs is a plus

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.

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Genomic Health is seeking a Sr. Program Manager with demonstrated interest, aptitude, and experience with IVD products to join our Product Development Program Management Team. The primary responsibility of this role will be to lead sub-teams within our complex IVD products and programs which include systems, assays, reagents, instruments, and software.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!