Job Description

Job Title: Sr. Manager, Design Compliance

Requisition ID:148549BR

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands 2013 Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services 2013 we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

Responsibilities:

* Assess product regulations and standards impact to meet global product requirements.
* Provide leadership to stakeholders to ensure global product compliance requirements are understood.
* Work closely with new product introduction teams to meet compliance requirements on schedule.
* Manage team resources and develop capacity analyses for Design Compliance.
* Provide matrix leadership and act as a KOL for the Design Compliance organization.
* Ensure accurate results, adherence to Company protocols, timely completion of projects, and the creation of Design History Files.
* Participates on team projects and assignments, facilitating or leading teams, as necessary.
* Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulatory and international standards.
* Provides direction and guidance to other Design Compliance engineers as needed
* Actively identify and lead initiatives toward continuous development, training, mentoring and/or coaching of staff in the Global Quality organization.
* This position is responsible for other duties as assigned.

Requirements / Education:

* Experience in leading and managing remote teams.
* Demonstrated experience on Design Control for IVD or Medical device industries.
* Demonstrated experience on Software development projects/products for IVD or Medical devices industries.
* Demonstrated ability to manage & implement multiple, large scale projects with minimal supervision, across the business &/or at remote &/or global locations.
* Must be able to influence & negotiate with people & resolve issues.
* Ability to make rational, objective & appropriate decisions relating to company & department needs & resource allocation.
* Bachelor degree (or higher) in a Technical Field.
* 8 years in a Design Compliance quality engineering role in regulated industry (IVD or Medical Device).
* In depth knowledge of Quality Systems, medical device/IVD manufacturing and regulatory requirements over a number of years.
* Excellent communication and presentation skills
* Ability to act independently, quickly, and decisively.
* ASQ certification is a plus

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.

*IND-LSG