Product Certification Safety- EE Contractor

Location: Lake Forest, CA
Salary: $50.00 USD Hourly - $75.00 USD Hourly
Description:
Minimum Qualifications

• Education: Bachelor's degree in Electrical Engineering or related field.
• Experience: 4+ years in medical device product safety compliance evaluations or experience in fully accredited test labs (e.g., UL, CSA, Intertek, Element).
• Expertise: Deep knowledge of IEC 60601-1 3rd Edition (including 3.1 and 3.2), collateral and particular standards for medical electrical equipment.
• Collaboration: Proven ability to work effectively with cross-functional teams.

Preferred Qualifications

• Working knowledge of ISO 14971 Risk Management for Medical Devices.
• Familiarity with EMC test planning and procedures per IEC 60601-1-2.
• Strong technical writing and presentation skills.

Responsibilities

• Perform safety certification assessments throughout the product development lifecycle, including early-stage evaluations to guide R&D.
• Plan and execute safety testing of electrical equipment for global market access.
• Conduct safety testing on Alcon products in internal and external labs.
• Prepare and maintain documentation for certification activities (e.g., isolation diagrams, dielectric and leakage current testing, construction evaluations using IEC test report forms).
• Communicate with internal/external labs, technicians, and design engineers to ensure timely, cost-effective results from quote to deliverables.
• Collaborate with teams to execute required testing and reviews, including pre-verification rehearsals to de-risk product launches.
• Document and execute all V&V tests in compliance with medical device QSR and ISO 13485.
• Develop detailed safety verification test plans and reports.
• Ensure compliance with product safety testing requirements and Alcon QMS standards, including production equivalency for test samples.
• Maintain and calibrate safety equipment; provide guidance to external labs for certification testing.
• Effectively communicate complex concepts through presentations and technical reports.

Skills

• Strong understanding of IEC 60601 standards and EMC practices.
• Ability to manage multiple projects and communicate risks with proposed solutions.
• Technical writing proficiency (assessed during interview).

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Contact:

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