Job Title: Senior Compliance Engineer
Requisition ID: 157830BR
When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
Provide guidance regarding product safety and product compliance requirements for bioproduction. This role is responsible for evaluating products to ensure they will meet applicable regulations including EMI/EMC, low voltage directive, product safety standards, and will be a key contributor to R&D during the development process for design to compliance. This is a remote role.
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
At Thermo Fisher Scientific, each one of our 80,000 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
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