Staff Product Safety Engineer
Core
Lead safety initiatives and drive strategic vision for new and existing orthopaedic instruments, ensuring compliance with global safety and regulatory standards throughout the product lifecycle.
Role type
Staff Product Safety Engineer
Builds
Orthopaedic Instruments (OI) business products
Domain
Medical Devices / Orthopaedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Product safety program planning, 60601 standard compliance, safety testing coordination, NRTL interface management, design analysis for safety, regulatory agency liaison
Preferred skills
Medical device safety testing, electrical testing equipment expertise, internal/external audit support, basic electrical circuits, EMC testing concepts, global wireless regulatory approvals (FCC/ISED/CE RED), Certified Test Facility (CTF) program participation
Technologies
60601, EMI/EMC, Wireless standards
Responsibilities
Support product safety activities for New Product Development and Product Engineering teams; Work with R&D teams to define and implement product safety program plans; Participate in product safety activities to represent and advance the interests of the product safety community; Support initiatives for product development teams with the technical understanding of 60601 and other required safety standards; Positively influence the R&D project teams to ensure compliance to the product safety standards; Collaborate with the team on design analysis to support the development of products within the boundaries of safety standards; Conduct, coordinate and evaluate results of safety testing, including EMI/EMC and Wireless; Serve as an interface between development teams and NRTLs or other regulatory agencies.
Seniority
Staff, strategic leadership & hands-on execution