Regulatory Safety and Compliance Engineer
Core
Ensure product safety and regulatory compliance during design and development projects for capital equipment.
Role type
Regulatory Safety and Compliance Engineer
Builds
Compliant capital equipment solutions for scientific customers
Domain
Capital equipment industry + global regulatory standards (OSHA, CE, EMC, Pressure Equipment)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Evaluate and interpret worldwide regulations and standards, Perform technical product design reviews, Coordinate product safety testing, Review and approve user manuals and labelling, Review engineering changes for compliance, Review 3rd party items for safety impact, Define product safety design guidelines
Preferred skills
Familiarity with OSHA, CE, Machinery Regulation, EMC directive, SEMI S2 & S8, NFPA79, Euratom ionizing Radiation directive, Pressure Equipment Directive, UL 61010-1:2012 / ANSI/ISA-61010-1 standard, Experience with certifications bodies (UL/TUV/Semi S2), Working knowledge of capital equipment industry, Ability to travel up to 25%
Technologies
OSHA, CE, Machinery Regulation, EMC directive, SEMI S2 & S8, NFPA79, Euratom ionizing Radiation directive, Pressure Equipment Directive, UL 61010-1:2012, ANSI/ISA-61010-1
Responsibilities
Evaluate and interpret regulations to guide design teams, Perform technical product design reviews, Coordinate product safety testing, Serve as primary interface with safety test labs, Create and ensure completion of regulatory safety test plans, Review and approve user manuals and safety labelling, Review engineering changes for compliance implications, Review 3rd party items for safety impact, Support business units and factories in product safety, Contribute to defining product safety design guidelines
Seniority
Mid-to-Senior level (requires BS + 10 years experience or equivalent)