Job Description –
Job Title:Tester
Duration:6+ Month
Location:Lake Forest, CA
Role Requirements:
- Minimum Education and Experience:
- 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
Core 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
- 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).
From:
Anju Pathak,
Tek Inspirations LLC
anju.pathak@tekinspirations.com
Reply to: anju.pathak@tekinspirations.com