Summary of position:
Alcon is looking to hire Sr. Manager product certification.
Core 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).
- Plan and execute Safety testing of electrical equipment and certification for global market access.
- Ensure compliance with Product Safety testing requirements and procedures per the governing standards and Alcon QMS. Includes ensuring test samples meet production equivalency requirements.
- Use and ensure maintenance of commonly used safety equipment, and calibration procedures. Provide guidance and requirements to external labs used for certification testing.
- Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs.
- Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practices.
Role Requirements:
1. Minimum Education and Experience: BS (preferably in EE or similar major) + 8 years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
2. Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) and IEC 60601-1-2 (Ed 4 and 4.1) of medical electrical equipment standards and including particulars & collateral standards. Proven experience in application to Electro-mechanical medical devices.
3. Proven experience in successfully being able to work with cross functional teams and lead the entire process for certification needs.
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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not 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 status, disability, or any other reason.
