Product Certification Safety- Electrical Engineer
Apply NowCompany: Futran Tech Solutions Pvt. Ltd.
Location: Lake Forest, CA 92630
Description:
Job Description & Skill Requirement:
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.
"LTTS is an Equal Opportunity Employer and maintains a clear policy against discrimination based on age, disability, sex, race, religion or belief, gender reassignment, marriage/civil partnership, pregnancy/maternity, or sexual orientation. As an inclusive organization, we actively endorse equal opportunities for all candidates with the right mix of talent, skills, and potential. We encourage applications from a diverse pool of candidates and selection for roles will solely be based on individual merit."
"L&T Technology Services LTD is an equal opportunity employer and is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require any accommodations to participate in the recruitment process or to perform the essential functions of the job, please let us know. We will work with you to provide reasonable accommodations in accordance with applicable law."
External Skills And Expertise
"Main Requirement:
The contractor is required to be able to work on site, should....
possess expertise in the IEC 60601-1 series of standards including applicable test methods on medical devices
and should have had some experience working within an accredited safety agency such as UL, TUV SUD, Intertek, CSA, etc."
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.
"LTTS is an Equal Opportunity Employer and maintains a clear policy against discrimination based on age, disability, sex, race, religion or belief, gender reassignment, marriage/civil partnership, pregnancy/maternity, or sexual orientation. As an inclusive organization, we actively endorse equal opportunities for all candidates with the right mix of talent, skills, and potential. We encourage applications from a diverse pool of candidates and selection for roles will solely be based on individual merit."
"L&T Technology Services LTD is an equal opportunity employer and is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require any accommodations to participate in the recruitment process or to perform the essential functions of the job, please let us know. We will work with you to provide reasonable accommodations in accordance with applicable law."
External Skills And Expertise
"Main Requirement:
The contractor is required to be able to work on site, should....
possess expertise in the IEC 60601-1 series of standards including applicable test methods on medical devices
and should have had some experience working within an accredited safety agency such as UL, TUV SUD, Intertek, CSA, etc."