Alcon · 2 months ago
Principal Engineer II, Product Certification
Lake Forest, California
Full-time
Onsite
Lead/Staff
$104K/yr - $156K/yr
8+ years expAlcon is a global leader in eye care, dedicated to enhancing sight and helping people see brilliantly. The Principal Engineer II, Product Certification will focus on improving quality and processes related to product safety certification, ensuring compliance with medical device standards and managing testing activities.
Health CareManufacturingMedical Device
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
Qualification
Required
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
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
Benefits
Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!
Life and disability insurance
Supports savings for retirement
Promotes good health and well-being
Supports associates and their families during times of illness
Company
Alcon
Alcon specializes in developing and manufacturing innovative medicines and devices to serve the cycle of eye care.
10001+ employees
H1B Sponsorship
Alcon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (35)
2023 (12)
2022 (15)
2021 (45)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
unknown2010-12-15Acquired
2002-03-21IPO
Leadership Team
David Endicott
Chief Executive Officer
Tim Stonesifer
Chief Financial Officer
Recent News
Business Wire
2026-01-07
Company data provided by crunchbase