Sr IVD Program Manager

Organization
Thermo Fisher Scientific
Job Location
Carlsbad, CA 92008
Job Description

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Responsibilities include:

  • Managing the overall project timelines, dependencies, resource planning, and phase deliverables

  • Conducting project and program level risk assessment and risk mitigation and contingency plans;

  • Guiding and driving the team to meet the “time-to-market” goal, designing and documenting the development plan and verification and validation efforts

  • Ensuring the products, studies and documentation meet regulatory and quality standards

  • Coaching others on design control, creating Design History Files, and managing the product traceability by working with cross functional team members

  • Overseeing deliverables from internal suppliers as well as the external suppliers or partners

Requirements

Requirements and Skills:

  • Diagnostic (IVD) product development skills and experience are required.

  • Must have a demonstrated track record in direct program management of projects that led to successful CE-IVD registration and 510K clearance; direct experience and good understanding of design controls and CE-IVD and 510k requirements

  • Must have a strong sense of ownership and commitment to projects assigned; must have a can-do attitude, and a willingness to drive towards goals, and a capability to drive the project at both the strategic level (overall vision and strategies) and the execution level (be a task owner, i.e. a “do-er”)

  • Basic project management skills (such as practicing PMBOK) and leadership skill is required;

  • Ability to positively influence project teams is required

  • Degree in a scientific/engineering discipline, such as molecular biology, biochemistry or genomics, engineering, is high desired

  • Excellent oral and written communication skill is required

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

How to Apply
About Our Organization

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

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