TSI provides trusted measurement, application guidance, and data analytics solutions that enable our global customers to make informed decisions. We are creating a better world by helping protect people, products and the environment, as well as by optimizing research and industrial processes. We hire curious, collaborative, and critical thinkers. Explore TSI careers!Independently participates with; new product development teams, outside experts as required, regarding domestic and international product compliance regulations.
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The Sr. Regulatory Engineer is responsible for participating in engineering projects from the concept phase through introduction to manufacturing as well as monitoring on-going compliance of products throughout its life cycle. The role is as a "regulatory subject matter expert" on all project teams providing guidance and decision making where needed. Oversight and facilitation of compliance testing as part of the projects. Communication skills are critical to the responsibilities of the Sr. Regulatory Engineer. This job requires maintaining relationships and significant interface with Engineering, Purchasing, Manufacturing, Marketing and Regulatory Agency personnel. Involvement or directing change to process and systems which involve Regulatory activities and how they fit to development, marketing, engineering and operations is as important as product compliance.
Facilitate implementation of current product standards requirements and assist marketing and engineering teams on product design activities to ensure compliance. Clearly presents information or provides explanations, so that it is easily understood.
Ensure all products have the correct labeling and markings, and that all user manuals and documentation have the appropriate notifications, warnings, and disclosures based on the functional specifications and intended use.
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Facilitate/Coordinate regulatory aspects of the projects, acting as key project interface to test labs, regulatory bodies, and countries. Ensure compliance testing stays on schedule.
Play an active role in the development team to insure that the compliance effort remains on schedule and within budget.
Obtain and maintain records of; testing, safety accreditation, CB Scheme, country licenses, etc.
Manages the ongoing regulatory compliance of TSI products through-out their life cycle by involvement with sustaining engineering projects.
Facilitate/participate in improving and or evolving Regulatory involvement within company processes; i.e., NPD, Operations, Sales, Marketing, International Offices, Service, etc.
Utilize knowledge of/or experience with the some of the following regulations / standards:
CE, EMC, RED, LVD Directives, Ag-Vehicle Directives
Safety; i.e., CSA, UL, ICES, PSE, RCM and other country specific regulations
Laser Safety, CDRH, Radiation Safety (X-ray, Radioactive) for USA and Foreign Countries
METAS, MCERTS, ATEX/IECEx (Industry regulation compliance)
RoHS/REACH/TSCA/Conflict Minerals/Prop 65/Montreal Protocol
Wireless: FCC, RED, BT/BTLE/WIFI/Cellular
- Bachelor's degree in an Engineering discipline is required.
- BS in Mechanical Engineering, Electrical Engineering or Manufacturing Engineering is preferred.
- A minimum of 5 years of product development experience in a regulated industry.
- A minimum of 5 years of experience in interpretation and application of regulatory agency product standards, country, and or industry regulations.
- Excellent computer skills. Proficiency required in using all core Microsoft Office products (Word, Excel, Outlook, and PowerPoint).
- Excellent verbal and written communication skills including active listening.
- Excellent presentation skills including leading groups and clearly explaining ideas visually on a whiteboard/flipchart.
- Expertise in application of associated standards including; UL, CSA, FCC, EN, Wireless, etc.
- Demonstrated ability to work directly with engineering staff and test/certification agencies
- Experience within a Design Assurance role
- Regulatory Certifications such as RAPS, ASQ Bio-Med/Auditor, ISO Lead Auditor
- Proficiency in Visio, and SharePoint
- Strong problem solving skills
Work is typically performed in a standard office setting working at a desk or table on a level surface. Air quality and noise levels are within normal limits. Eye protection is usually not required but may be required if working with certain laser types or automated equipment. Under normal conditions, exposure to excessive noise, dust, humidity, and fumes is rare. An employee may be required to work more hours than normally expected during a regular workweek depending on workload and deadline requirements.
Some travel may be required (5-10%).
TSI provides trusted measurement, application guidance, and data analytics solutions that enable our global customers to make informed decisions. We are creating a better world by helping protect people, products and the environment, as well as by optimizing research and industrial processes.Nearest Major Market:
Minneapolis Job Segment:
Regulatory Affairs, Compliance, Manufacturing Engineer, Engineer, Outside Sales, Legal, Engineering, Sales