Product Safety Engineer Job at Wipro, Lake Forest, CA

VmRWRTJ1VUlXWnZmdkh3cmxPZlIvaDRLcWc9PQ==
  • Wipro
  • Lake Forest, CA

Job Description

  • 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.
  • 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
  • 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

Job Tags

Similar Jobs

Four Seasons

Purchasing Storeroom Clerk Job at Four Seasons

Four Seasons - 10600 East Crescent Moon Drive [Retail Associate / Team Member] As a Storeroom Clerk at Four Seasons, you'll: Maintain accurate inventory records; Monitor stock levels and order supplies as needed; Receive and inspect deliveries; Organize and store items ...

SkyRite

Metal Fabricator Job at SkyRite

 ...Job Description Job Description Are You Ready to Build Something Incredible? Join SkyRite as a Metal Fabricator! Do you have at least 2 years of metal fabrication experience? Are you ready to start a new and rewarding career in the exciting sign industry? At SkyRite... 

The UPS Store Food Lion Shopping Center #6186

Full-Time UPS Store Associate Job at The UPS Store Food Lion Shopping Center #6186

***BEFORE READING FURTHER, PLEASE BE AWARE THAT THIS JOB POSTING IS FOR A PRIVATELY OWNED AND OPERATED UPS STORE FRANCHISE. YOU ARE NOT APPLYING TO WORK FOR 'UPS' THE COMPANY (WITH THE BROWN TRUCKS). WE DO NOT DELIVER PACKAGES.***We are a business of two local UPS Store... 

Berks County

Park Attendant (Part-time) Job at Berks County

 ...Job Description POSITION SUMMARY: Park Attendants are part-time, year-round, and seasonal employees responsible for overseeing all picnic reservations, meetings, wedding groups, and other special functions, i.e., fundraising walks and runs at any Park facility. The... 

Princeton Staffing Solutions

Travel Speech Language Pathologist Assistant (SLPA) - $1,644 per week Job at Princeton Staffing Solutions

 ...Princeton Staffing Solutions is seeking a travel Speech Language Pathologist Assistant (SLPA) for a travel job in Albany, Oregon. Job Description & Requirements ~ Specialty: Speech Language Pathologist Assistant (SLPA)~ Discipline: Therapy ~ Duration: 13 weeks...