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Product Compliance IEC-60601 Engineer

Company: L&T Technology Services Limited
Location: Milpitas
Posted on: April 9, 2021

Job Description:

Responsibilities Include (but are not limited to):--- Performing Gap assessments between standard editions and how new clauses impact product design, testing and documentation.--- Working with test lab to identify compliance testing needs.--- Writing test plans, protocols and reports for compliance testing. This includes working with the development team to identify modes to be tested and acceptance criteria.--- Working with test lab and J&J internal groups to coordinate schedules and logistics of transporting equipment to test labs and performing compliance testing to meet project schedules.--- Working with the test engineers during compliance testing to ensure they are trained on using the equipment, understand the test plan and to resolve issues.--- Working with the development and quality teams to create checklists.--- Providing input to the development and quality teams on requirements, risk inputs, labeling, usability and J&J operating procedures as they relate to ensuring compliance with relevant standards.--- Working with the test labs to ensure the testing is performed correctly, completing and reports are correct and complete.--- Working with development team and quality to obtain all documentation (labeling, checklists, etc) necessary for the test lab to perform the compliance evaluations and obtain CB Certificates and radio certifications.--- Working with development engineers to create any fixtures or configure samples for compliance and radio testing.--- Working with vendors/suppliers to obtain test setups such as drivers, firmware or tools specific to the unit under test.Qualifications:--- Good understanding of medical standards (IEC 60601-1, IEC 60601-1-2)--- Preferred: Working knowledge of RF devices and global regulation such as FCC 47CFR part 15, EU RED, etc.

Keywords: L&T Technology Services Limited, Milpitas , Product Compliance IEC-60601 Engineer, Engineering , Milpitas, California

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