What are the responsibilities and job description for the Product Certification Safety- Electrical Engineer position at Fusion Life Sciences?
Job Details
Product Certification Safety- Electrical Engineer
Core responsibilities:
Perform Safety certification test assessments throughout the development lifecycle
including early stages to provide the necessary inputs to R&D to drive product
development.
Support development including planning, communicate periodic status and known risks
(with proposed solutions) on the projects to R&D core teams
Capable of performing safety testing and of Alcon products in the Alcon safety Lab and
external labs.
Prepare documentation to execute safety certification activities Isolation Diagrams,
perform Dielectric and Leakage current testing, Construction evaluation using IEC
generated test reports forms
Communicate with internal/external labs, technicians, and design engineers to accomplish
timely/valuable results at optimal cost (from Quote request to final deliverables).
Collaborate with teams to ensure full execution of identified required testing and review
activities needed to ensure product compliance including de-risking product launches
through pre-verification test rehearsals.
Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare
clearly written, accurate, highly detailed Safety verification test plans and test reports.
Effectively communicate complex concepts in formal/informal presentations and in
technical reports; proven technical writing skills is required (assessed during 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 Alcon QMS. Includes ensuring test samples meet production
equivalency requirements.
Use and ensure maintenance of 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
products 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.
Core responsibilities:
Perform Safety certification test assessments throughout the development lifecycle
including early stages to provide the necessary inputs to R&D to drive product
development.
Support development including planning, communicate periodic status and known risks
(with proposed solutions) on the projects to R&D core teams
Capable of performing safety testing and of Alcon products in the Alcon safety Lab and
external labs.
Prepare documentation to execute safety certification activities Isolation Diagrams,
perform Dielectric and Leakage current testing, Construction evaluation using IEC
generated test reports forms
Communicate with internal/external labs, technicians, and design engineers to accomplish
timely/valuable results at optimal cost (from Quote request to final deliverables).
Collaborate with teams to ensure full execution of identified required testing and review
activities needed to ensure product compliance including de-risking product launches
through pre-verification test rehearsals.
Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare
clearly written, accurate, highly detailed Safety verification test plans and test reports.
Effectively communicate complex concepts in formal/informal presentations and in
technical reports; proven technical writing skills is required (assessed during 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 Alcon QMS. Includes ensuring test samples meet production
equivalency requirements.
Use and ensure maintenance of 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
products 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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