Safety Engineer
Core
Provide engineering leadership and expertise to support new and existing products, processes, prototypes, fixtures, and tools for the Core Lab business, applying engineering principles to solve technical problems and ensure product safety compliance.
Role type
Product Safety Engineer
Builds
Medical diagnostic instruments and systems
Domain
Healthcare / Medical Devices
Required skills
Product safety standards knowledge (UL/CSA/IEC), test setup and execution, systems-level compliance approach, regulatory reporting (CDRH, ISO 17025), engineering design and fabrication, statistical analysis, problem-solving tools
Preferred skills
Medical device product safety testing, laboratory environment experience, EMC/Safety assessments, hands-on technical knowledge of safety test methods and equipment
Technologies
UL/CSA/IEC 61010-1, IEC 60825-1, ISO 17025, CDRH
Responsibilities
Facilitate systems-level approach to Product Safety compliance for new product development and design changes, conduct quarterly UL audits and address variation notices, create and update internal test procedures per external standards, maintain lab areas in audit readiness following cGMP practices, perform basic EMC/Safety assessments for design changes, lead and participate in projects involving design and fabrication of complex instrument subassemblies
Seniority
Mid-level, hands-on IC