Principal Compliance Systems Engineer

BS or MS in an applicable engineering discipline with 5 or more years of experience in the design and implementation of complex systems.
Knowledge of EMC regulations and certification procedures applicable to Electromechanical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e. EN14971, EN60601, CISPR 11, FCC, EU etc.).
Experience in compliance engineering on complex design projects utilizing formal standards testing methodologies.
Experience in Requirements and Risk Management, Configuration Management, Issue Management and Traceability.
Experience in resolving complex technical problems in collaboration with design engineers.
Demonstrated experience interfacing with certification bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).

Ensures Infusion Systems hardware solutions comply with applicable standards.
Collaborate with design engineers to develop product requirements that comply with standards and regulations for intended global markets.
Cascade system compliance requirements to subsystem requirements to ensure overall design for compliance.
Develop Compliance Plans, participate in design and development activities (Technical Reviews and Design Reviews) and resolve product certification, compliance and safety issues.
Develop product certification strategy and resolve compliance issues for complex medical devices.
Ensures compliance with product related environmental regulations (e.g. REACH, RoHS).
Keep abreast of changes to product standards and regulations affecting medical products.
Work with Verification team to review compliance testing plans to ensure compliance to recognized standards and test methods.
Submit documentation to certification bodies and regulatory authorities as required to obtain product certifications.

No preferred qualifications provided.