Medical Device Safety Engineer
The Judge Group Inc.

Job Info

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Location: Lake Forest, CA
Description:
Our client is seeking to add a Medical Device Safety Engineer for long-term project. Please evaluate the summary and apply if your background is a good fit. Looking forward to working with you!

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 products in the 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).
• Experience with Safety testing of electrical equipment and certification for global market access.
• Experience with Product Safety testing requirements and procedures.
• Experience with use and maintenance of commonly used safety equipment, and calibration procedures.
• Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs.

Role Requirements:

• Minimum Education and Experience:
• BS + 2 years in medical device products safety compliance, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
• Working 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 successfully being able to work with cross functional teams

Reach the Poster: Scorbray@judge.com

Contact: scorbray@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.