Job Description

Title: Compliance Engineer

Location: Lake Forest Drive, Lake Forest, CA

Submission Requirements: Driver's License and H1 Copy

NOTE:-

• Kindly note, the role requires expert-level knowledge of IEC 60601-1 testing .
• The client is open to H1B, U.S. Citizens, and Green Card holders.

Job Description:

The contractor will work onsite and must possess expertise in the IEC 60601-1 series of standards , including applicable test methods for medical devices. Experience with accredited safety agencies such as UL, TUV SUD, Intertek, CSA, etc., is preferred.

Role Requirements:

1. Education & Experience:

• BS in Electrical Engineering (or related field) + 4 years of experience in medical device product safety compliance or fully accredited test labs (e.g., UL, CSA, Intertek).

1. Standards Expertise:

• Expert knowledge of IEC 60601-1 (3rd Ed: 3.1, 3.2) standards, including collateral and particular standards for medical electrical equipment.

1. Collaborative Skills:

• Proven ability to work effectively with cross-functional teams.

Core Responsibilities:

• Conduct safety certification test assessments throughout the development lifecycle.
• Provide input to R&D teams for product development and risk mitigation.
• Perform safety testing on Alcon products in both internal and external labs.
• Prepare documentation for safety certification activities, including isolation diagrams, dielectric testing, and construction evaluations.
• Coordinate with labs, technicians, and design engineers to achieve optimal testing outcomes.
• Document and execute verification and validation tests compliant with medical device regulations (QSR, ISO 13485).
• Prepare comprehensive test plans and reports with strong technical writing skills.
• Plan and execute global safety certification testing of electrical equipment.
• Maintain safety equipment and ensure calibration standards.
• Familiarity with ISO 14971 Risk Management and IEC 60601-1-2 EMC testing procedures is highly desirable.

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