Safety EMC Engineer
The Judge Group Inc.

Job Info

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Location: Lake Forest, CA
Salary: Negotiable
Description: Our client is currently seeking a Safety EMC Engineer! This is a 12+ month contract in Lake Forest, CA. Fully onsite.

Looking for someone with experience testing to 60601-1 standard. Must have medical device experience. Please apply if this sounds like you!

Role Requirements:

Minimum Education and Experience:

• Bachelor's degree with 4+ years in medical device product safety compliance, or experience as a medical device product safety officer in a medical device manufacturer or fully-accredited test labs (e.g., Element, UL, CSA, Intertek).

Proven Experience:

• Successful collaboration with cross-functional teams.

Core Responsibilities:

• Conduct EMC and Wireless test assessments throughout the development lifecycle, providing necessary inputs to R&D to drive product development.
• Research and develop product EMC & Wireless requirements, including selecting applicable standards and tests, to support global market access strategies for electromechanical surgical instruments.
• Utilize specialized EMI/EMC hardware and software in all stages of product development at both the circuitry (PCB) and system levels.
• Plan and communicate periodic status and known risks (with proposed solutions) to R&D core teams.
• Perform EMI/EMC testing and troubleshooting of products in both internal and external labs.
• Communicate with internal/external labs, technicians, and design engineers to achieve timely and valuable results at optimal cost.
• Collaborate with teams to ensure full execution of required testing and review activities, ensuring product compliance and de-risking product launches through pre-verification test rehearsals.
• Document and execute all V&V tests compliant with medical device QSR and ISO 13485. Prepare detailed EMC and Wireless verification test plans and reports.
• Effectively communicate complex concepts in presentations and technical reports; proven technical writing skills required.
• Experience with EMC testing of electrical equipment and certification of wireless devices for global market access.
• Experience with product safety testing requirements and procedures.
• Proficient in using and maintaining commonly used EMC and wireless test equipment.
• Working knowledge of IEC 60601-1-2 and IEC 60601-4-2 medical standards. Experience with IEC 60601 series standards is a plus.
• Ability to influence effectively in a cross-functional environment (e.g., multi-site, technical development, other functions).

Contact: arobinson@judge.com

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

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