Product Compliance IEC-60601 Engineer
Company: L&T Technology Services Limited
Location: Milpitas
Posted on: April 9, 2021
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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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