Job Description

Job Title: Medical Device Project Manager

Requisition ID: 148877BR

When you join us at Thermo Fisher Scientific, you2019ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 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.

Location/Division Specific Information

The Life Sciences Mass Spectrometry development team is seeking an exceptionally talented project manager to perform in a project management role in the design and development of technology that is critical in supporting Thermo Fisher Scientific2019s position as the leader in mass spectrometry. She/he must be comfortable working in and leading a group of cross-functional, and possibly cross business unit teams including R&D, Marketing, Operations, Sourcing and Product Evaluation. The responsibilities of this technical management/ organizational role include defining, coordinating, and helping drive the development of new product offerings. Given the interdisciplinary nature of Life Science Mass Spectrometry, this role will require familiarity and interplay with the entire hardware team and several adjacent disciplines, including various software and engineering groups, operations, product support and marketing.

How will you make an impact?

Manage medical device (specifically IVD) projects from concept creation through product development and into release to operations & the commercial market. This includes creating documentation to define system requirements and specifications, managing scientist, engineers and external contractors through development, validation, documentation and release of products.

What will you do?

* Work with a multi-disciplinary product development team and possibly cross business unit to develop, evaluate, document, and introduce new products or enhancements for mass spectrometer systems.
* Provides leadership and problem-solving for multi-faceted, cross-functional Research & Development teams.
* Selects and coordinates work of multi-site teams and/or contractors working on various phases of the project.
* Participate in the development and documentation of instrument control software and firmware.
* Provide expertise in project planning and timeline development & management. Develops a cost-effective plan and schedule for completion of project following a logical pattern for utilization of resources.
* Track and control progress, schedule and associated costs to achieve completion of project within time and budget.
* Review all designs and validations to make sure that all specifications are being met.
* Effectively work with and influence team functional representatives
* Conduct appropriate project risk assessments and defining a mitigation plan
* Report to stakeholders and upper management about progress and any necessary modifications of plans.
* Develop approaches to sustain and communicate success and progress across global stakeholders.
* Other duties as assigned

How will you get here?

Education

B.S. in Engineering, Chemistry, Physics, or a related scientific discipline or equivalent combination of education/experience.

Experience

* Proven track record of 5 years of experience in development project leadership, project management, program strategy, scope & resource definition, possibility/solution work stream generation, knowledge management, and its transition to applications
* Ability to work under pressure and coordinate numerous activities with a multi-disciplinary team of engineers and scientists who need to communicate and cooperate to achieve maximum efficiency.
* Excellent written and oral communication skills.

Knowledge, Skills, Abilities

* Leadership: Ability to lead multi-faceted cross-functional teams
* Experience in managing technical challenges
* Experience managing several complex projects and priorities
* Highly effective organization, negotiation, coordination, and presentation skills
* Ability to communicate effectively over the phone, online, and in person
* Meeting facilitation skills
* Experience writing scope statements
* Strong understanding of linking research to business opportunity
* Experience working in an ISO 9001/ ISO13485 and 21CFR820 regulated environment is required.
* Knowledge of EC 2017/746 (Invitro-Diagnostic Regulation) required.
* Familiarity with medical device standards, such as; ISO 14971, ISO 62304, ISO 62366, IEC 61010, and IEC 60601 required.
* Strong familiarity with PMI methodology
* Team Work: Ability to manage multiple priorities, think on their feet, and execute with speed
* Initiative and follow through: Independent decision maker in a fast paced and demanding environment

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission2014enabling 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.