Principal Engineer II, Product Certification

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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 Alcons 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 IECIECmedical 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

What Youll Bring to Alcon:

• Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 yrs)

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

• 5 Years of Relevant Experience

How You Can Thrive at Alcon:

• Join Alcons 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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Alcons Total Rewards programs are designed to align to incentives with business goals encourage the right values and behaviors and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay which includes short-term incentives and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance supports savings for retirement promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcons Corporate Social Responsibility including our Total Rewards click here

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.