Sr. Design Compliance Engineer

Location
Pleasanton, CA
Salary
Competitive
Posted
March 20 2017
Ref
40427BR
Position Type
Full Time
Job Description
  • Provides guidance for: Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews.
  • Identifies the opportunities for continuous improvement of the Design Control process within the Quality System, design document generation, and design testing processes.
  • Participates on team projects and assignments, facilitating or leading teams as necessary to support NPIs.
  • Provides guidance to test methods, equipment acquisition, sample plan definition, and validation development.
  • 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 within Design Compliance team as needed.

REQUIREMENTS / EDUCATION:

  • Demonstrated experience on Design Control for IVD or Medical device industries (CE IVD, FDA IVD, etc).
  • Demonstrated change agent for Quality Systems - that includes ability to challenge the status quo & effecting change to achieve business results.
  • Demonstrated ability to manage & implement multiple, large scale projects with minimal supervision, across the business &/or at remote &/or global locations.
  • Requires the ability to perform independently & as part of a team.
  • Must be able to influence & negotiate with people & resolve issues.
  • Ability to make rational, objective & appropriate decisions relating to company & department needs & resource allocation.
  • Ability to identify customer needs, issues and develop realistic solutions to meet needs & solve problems.
  • Ability to communicate recommendation and decisions across a wide spectrum of the organization.
  • Bachelor degree (or higher) in a Technical Field.
  • 6 years in a Design Compliance quality engineering role in regulated industry (IVD or Medical Device).
  • In depth knowledge of Quality Systems, IVD/medical device/Pharma manufacturing and regulatory requirements over a number of years.
  • Excellent communication and presentation skills



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.