| Compliance Engineer || Lake Forest, CA || Onsite || Local Only at Forest, Virginia, USA |
| Email: [email protected] |
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From: Roopesh Sharma, VIZON INC [email protected] Reply to: [email protected] Job Title: Compliance Engineer Location: Onsite in Lake Forest, CA, must be local Status: only USC or GC Medical Device Safety Compliance Role Requirements: Bachelor's degree in Electrical Engineering (or a related field) preferred. Minimum of 4 years of experience in medical device product safety compliance evaluations and/or working in fully accredited test labs such as UL, CSA, Intertek, or Element. Expertise: 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 applying these standards to electromagnetic medical devices. Demonstrated ability to work effectively with cross-functional teams. Core Responsibilities: Conduct safety certification test assessments throughout the product development lifecycle, providing necessary inputs to R&D to guide 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 Alcon products in both the Alcon safety lab and external labs. Prepare documentation for safety certification activities, including isolation diagrams, dielectric and leakage current testing, and construction evaluation using IEC-generated test report forms. Communicate with internal and external labs, technicians, and design engineers to achieve timely and valuable results at optimal costs, from quote requests to final deliverables. Collaborate with teams to ensure full execution of required testing and review activities 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 standards. Prepare clear, accurate, and detailed safety verification test plans and reports. Effectively communicate complex concepts in both formal and 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 governing standards and Alcon QMS, including ensuring test samples meet production equivalency requirements. Maintain and use 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. Keywords: rlang green card California Delaware Compliance Engineer || Lake Forest, CA || Onsite || Local Only [email protected] |
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| 06:18 AM 06-Feb-25 |