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
