Senior Engineer, Compliance
Core
Ensure Leica medical/life science products comply with global safety and regulatory standards (CCC, UL, RoHS, etc.) and manage product risk.
Role type
Senior IC compliance engineer (medical/life science)
Builds
Compliant medical/life science products for global customers
Domain
Medical devices / Life sciences / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (ISO 14971), Regulatory standards interpretation, EMC testing, Safety testing, Transportation/Environment testing, RoHS/REACH compliance, Electrical engineering knowledge, Mechanical engineering knowledge
Preferred skills
Medical device or life science product development experience
Technologies
IEC61010, IEC61326, ISTA 2B/3A, CSA61010, FCC Part15, ISO 14971
Responsibilities
Execute risk analysis for Leica products; Monitor regulation updates and generate action plans; Execute independent EMC, Safety, and Transportation/Environment tests in 3rd-party labs; Ensure RoHS/REACH compliance for components; Develop compliance test and validation plans.
Seniority
Senior, hands-on IC