Product Safety Engineer - Katalyst Healthcares & Life Sciences

• 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, communicating 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).

Requirements:

• BS + 4 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.

• Proven experience in successfully being able to work cross functional teams.

• 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).