Safety Compliance Engineer at The Judge Group Inc. in Lake Forest, California

Job Description:

Location: Lake Forest, CA

Salary: $50.00 USD Hourly - $100.00 USD Hourly

Description:

Safety Compliance Engineer




Location: On-site



Role Requirements:

Minimum Education and Experience:

• Bachelor's degree (preferably in Electrical Engineering or a related field) + 4 years of experience in medical device product safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek, or Element.

Expert Knowledge:

• In-depth knowledge of IEC 60601-1 3rd Edition (3.1 and 3.2) standards for medical electrical equipment, including particulars and collateral standards. Proven experience in applying these standards to electromagnetic medical devices.

Team Collaboration:

• Demonstrated ability to work effectively with cross-functional teams.

Core Responsibilities:

• Conduct safety certification test assessments throughout the development lifecycle, including early stages, to provide necessary inputs to R&D for driving product development.


• Support development by planning, communicating periodic status updates, and identifying known risks (with proposed solutions) to R&D core teams.


• Perform safety testing of Client products in the Client safety lab and external labs.


• Prepare documentation to execute safety certification activities, including isolation diagrams, dielectric and leakage current testing, and construction evaluation using IEC-generated test report forms.


• Communicate with internal/external labs, technicians, and design engineers to achieve timely and valuable results at optimal cost (from quote request to final deliverables).


• Collaborate with teams to ensure full execution of required testing and review activities needed to ensure product compliance, including de-risking product launches through pre-verification test rehearsals.


• Document and execute all verification and validation (V&V) tests compliant with medical device QSR and ISO 13485. Prepare clearly written, accurate, and highly detailed safety verification test plans and test reports.


• Effectively communicate complex concepts in formal/informal presentations and technical reports; proven technical writing skills are required (assessed during the interview).


• Plan and execute safety testing of electrical equipment and certification for global market access.


• Ensure compliance with product safety testing requirements and procedures per the governing standards and Client's QMS. This includes ensuring test samples meet production equivalency requirements.


• Use and maintain commonly used safety equipment and calibration procedures. Provide guidance and requirements to external labs used for certification testing.


• Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device product safety compliance, and/or fully accredited test labs.


• Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practices.

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Contact: tespensen@judge.com


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