Principal Engineer II, Product Certification

Principal Engineer II, Product Certification page is loaded## Principal Engineer II, Product Certification locations:
Lake Forest, California time type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
January 31, 2026 (30+ days left to apply) job requisition :
R-The Principal Engineer II, Product Certification is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes and will be located at our R&D facility in Lake Forest, CA.
** In this role, a typical day will include:
*** 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.
*
* Experience:

*** BS (preferably in EE or similar major)
* 8+ years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
* Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards.
* Proven experience in application to EM medical devices.
* Proven experience in successfully being able to work with cross functional teams
** What You'll Bring to Alcon:
*** Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
* The ability to fluently read, write, understand, and communicate in English
* 5 Years of Relevant Experience
** How You Can Thrive at Alcon:
*** Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
* Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!
* Travel Requirements: 0-5%
* Relocation assistance:
Yes
* Sponsorship available:
Yes
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Current Alcon Employee/Contingent Worker
** If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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