When you re part of the team at Thermo Fisher Scientific, you ll do important work. Surrounded by collaborative colleagues, you ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
Senior Compliance Specialist will provide guidance to Engineering, Management, R&D, and Operations teams regarding Product Safety and all product Compliance requirements. This role is responsible evaluating products to ensure they will meet applicable regulations including EMI/EMC, MDD, EU Low Voltage Directive (20154/35/EU), product safety standards, and environmental regulations. Position requires key contributions to Research and Development during various phases of the New Product Development process. The Senior Compliance Specialist will maintain competence, capability and adequate capacity through a combination of internal and 3rd party resources. This role will also maintain prioritized plans and schedules, and provide reporting for management. The Senior Compliance Specialist keeps informed of emerging global regulatory requirements, and recommends compliance strategies to avoid disruption of new product introduction schedules.
- Prevents compliance issues by collaborating with engineering planning and design teams; reviewing design data; identifying and resolving product and engineering design issues; identifying short-term and long-range issues; researching and identifying applicable regulatory and industry compliance standards and codes; developing compliance policies.
- Develops compliance plans by researching, analyzing, selecting, and applying compliance engineering concepts, approaches, techniques, and criteria; adapting and modifying compliance engineering options; developing and evaluating new compliance methodologies; qualifying vendors, components, and parts.
- Organizes compliance program by preparing timetables, cost estimates, and required resources including test laboratories and equipment.
- Determines compliance by establishing compliance test standards; conducting and witnessing tests; performing diagnostic procedures; measuring performance; analyzing and evaluating findings; performing forensic analysis of failures; troubleshooting failures; supervising sub-contractors.
- Attains compliance by isolating and resolving non-compliance issues; recommending product and process changes; initiating engineering change orders.
- Documents compliance by completing approval applications; recording test results; preparing investigative reports; preparing and filing Declarations of Conformity; maintaining compliance database.
- Maintains engineering team accomplishments by reviewing open issues and action items; coordinating actions; contributing information and analysis to team meetings and reports.
- Updates job knowledge by participating in educational opportunities and professional organizations; professional publications and maintaining personal networks.
- 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 on-going compliance with safety and other regulations.
- Coordinate testing with outside agencies for third party Product Safety and EMC test and certification.
- Experience with electro-mechanical design, and/or ProE/SolidWorks CAD systems is a plus.
- Schedule and coordinate resources for third party Field Evaluations where required for particular installations/customers.
- Maintain PS&C in-house and third party Safety and EMC database.
- Prepare and publish Declarations of Conformity.
- This position is responsible for other duties as assigned.
- Bachelor s degree in a Technical or Engineering discipline required.
- Minimum of ten years product safety and compliance experience with emphasis on analog electronics.
- Must have knowledge of, and experience with, electrical and electro-mechanical devices and relevance product Safety regulations: IEC/UL 61010-1; IEC/UL 60601-1 or IEC/UL 60950-1.
- Must have experience conducting electrical safety tests including: Dielectric Strength, Ground Bond, Current Leakage, and Continuity.
- Through knowledge and experience with Electronic Test and Measurement Equipment.
- Proven consultative skills to effective outcomes.
- Competence with Microsoft Office Suite
- Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.
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 Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.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.
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