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Alcon · 1 month ago

Principal Engineer II, Product Certification

Lake Forest, CA

Full-time

Onsite

Senior Level, Lead/Staff

5+ years exp

Alcon is a global leader in eye care, dedicated to enhancing sight and improving lives. The Principal Engineer II, Product Certification will focus on improving quality and processes for electromechanical surgical instruments, ensuring product compliance through rigorous testing and collaboration with cross-functional teams.

Health CareManufacturingMedical Device

H1B Sponsored

Responsibilities

Perform EMC and Wireless test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development

Research and develop product EMC & Wireless requirements including selection of applicable standards & tests, with analyses to support Alcon’s global market access strategies for all electromechanical surgical instruments

Support product development utilizing specialized EMI/EMC hardware and software within all stages of product development at the circuitry level (PCB level) as well as at the system level

Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams

Capable of performing EMI/EMC testing and troubleshooting of Alcon products in the Alcon EMC Lab and external labs

Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost

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 EMC and Wireless 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)

Experience with EMC testing of electrical equipment and certification of wireless devices for global market access

Experience with Product Safety testing requirements and procedures

Experience with use and maintenance of commonly used EMC and wireless test equipment

Working knowledge of IEC 60601-1-2, IEC 60601-4-2 medical standards. Proven experience in applying state of the art EMC and RF design principles. Knowledge of IEC 60601 series of standard would be a plus

Influence effectively in a cross-functional environment (e.g. multi-site, technical development, other functions)

Qualification

EMC testingWireless certificationIEC 60601 standardsTechnical writingCross-functional collaborationProblem-solvingCommunication skillsTeamwork

Required

BS (preferably in EE or similar major)

2+ years in medical device products safety compliance, or successfully working as medical device product safety officer in either/both medical device manufacturer and/or fully-accredited test labs such as Element, UL, CSA and Intertek, 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

The ability to fluently read, write, understand, and communicate in English

5 Years of Relevant Experience

Perform EMC and Wireless test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development

Research and develop product EMC & Wireless requirements including selection of applicable standards & tests, with analyses to support Alcon's global market access strategies for all electromechanical surgical instruments