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Thermo Fisher Scientific Senior Compliance Engineer in Fremont, California

Job Title: Senior Compliance Engineer

Requisition ID: 181071BR

When your part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you will be supported in achieving your career goals.

Location/Division Specific Information

The Senior Compliance Engineer will provide guidance regarding product safety and product compliance requirements for bioproduction in Santa Clara, CA. This role is responsible for evaluating products to ensure they will meet applicable regulations including EMI/EMC, low voltage directive, product safety standards, and is a key contributor to R&D for design to compliance.

How will you make an impact?

We develop innovative tools supporting the production of life saving therapies and vaccines. This role brings you the opportunity to firmly apply your stamp to our products, now and well into the future. Join us in making the world healthier and safer.

What will you do?

  • Work with Product Development to develop compliance plans by researching, analyzing, selecting, and applying compliance engineering concepts and criteria; adapting compliance engineering options; developing new compliance methodologies.

  • Determine compliance test standards; conducting/oversee tests; performing diagnostic procedures; measuring performance; analyzing and evaluating findings; performing forensic analysis of failures; troubleshooting failures; supervising sub-contractors.

  • Prevents compliance issues by collaborating cross functionally to review data, identifying and resolving product and engineering design issues; identify short-term and long-range issues; researching and identifying applicable regulatory and industry compliance standards and codes..

  • Organize compliance program by preparing timetables, cost estimates, and required resources and drive to completion.

  • Document compliance, prepare and file Declarations of Conformity.

  • Perform in-house safety testing of components where properties cannot be identified through documentation.

  • Review all new part requests, engineering change orders and deviations to ensure that requirements are met and maintained.

  • Stay abreast of all upcoming changes to Product Safety and Compliance regulations and standards to ensure the organization is meeting all current requirements for new and legacy products. Assess product regulations and standards impact of new market entries (e.g., as associated with expansion into new countries, applications, etc.).

  • Interface with outside agencies so that the products can be formally tested and certified to meet designated requirements, including US and Canada NRTL requirements.

How will you get here?

  • BS degree in Electric or Mechanical Engineering or equivalent.

  • 3 year of experience working with Safety and EMC compliance labs to certify products.

  • Working knowledge of Machinery Directive, EN/UL/CAN 61010-1 and EN 61326-2 with “hands-on” testing experience a plus.

  • Experience working with electrical and electro-mechanical products

  • Experience conducting electrical safety tests including: Dielectric Strength (HiPot), Ground Bond, Leakage (Touch Current), and Continuity.

Knowledge, Skills, Abilities

  • Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.

  • Demonstrated excellent communication skills orally, written and presentation group settings.

  • Demonstrated teamwork and problem-solving skills

  • Experience with mechanical safety requirements.

  • Familiarity with product environmental regulations and standards such as E.U. RoHS, REACH and WEEE directives and US Conflict Minerals requirements is a plus.

  • Demonstrated ability to take ownership of a problem and drive to implement at solution as an individual and as a team player

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.