Job Details

Title: Electrical Tester

Location: Lake Forest, CA

About the Role

Responsibilities

• Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
• Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams
• Capable of performing safety testing and of Alcon products in the Alcon safety Lab and external labs.
• Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms
• Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost (from Quote request to final deliverables).
• 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 Safety 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).

Qualifications

BS (preferably in EE or similar major) + 4 years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.

Required Skills

Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards.

Preferred Skills

Proven experience in application to EM medical devices. Proven experience in successfully being able to work with cross functional teams.