Principal Engineer II, Product Certification

Alcon Research•Lake Forest, CA

12h•Onsite

About The Position

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? 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 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). Experience: 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

Requirements

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.
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
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

Nice To Haves

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).

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).