Senior Compliance Engineer
Core
Ensures Abbott Neuromodulation implantable and wireless medical devices comply with global safety, EMC, and regulatory standards throughout the product lifecycle.
Role type
Senior IC compliance engineer (medical devices)
Builds
Safe and compliant neuromodulation products for patients with chronic pain and movement disorders
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
interpreting technical standards, developing compliance test plans, executing compliance testing, performing impact assessments, root cause analysis, technical writing
Preferred skills
knowledge of IEC 60601 series, ISO 14708 series, IEC 62304, ISO 10993, FCC, RED, experience with Class II/III medical devices, experience with implantable/wireless systems
Technologies
IEC 60601, ISO 14708, IEC 62304, ISO 10993, FCC, RED
Responsibilities
Evaluate product designs against national and international standards, develop compliance strategies and test protocols, collaborate with cross-functional teams to integrate compliance requirements, partner with external labs for certifications, monitor regulatory revisions, investigate compliance issues and develop corrective actions
Seniority
Senior, hands-on IC