Senior Regulatory Compliance Engineer

  • Illumina
  • US - California - San Diego
  • Mar 26, 2020
Full time Biotech

Job Description

  • The Compliance Engineer will participate in projects obtaining agency approvals for new and legacy products. The job requires experience with obtaining FCC, CE, EMC/RED, IC and safety certifications. Experience is required with the relevant UL, CSA, FCC, IEC and EN directives and standards. Experience with RoHS, WEEE, REACH, Prop65 and other environmental regulations is a plus. The engineer will develop compliance test plan encompassing EMC, EMI, safety, environmental, and other product compliance requirements.




    • Read, interpret and communicate changes in technical regulations, directives and standards

    • Review new and existing designs for compliance to the latest directives and standards

    • Manage projects with test labs -some local travel required

    • Coordinate any necessary changes with mechanical, electrical, and software engineers

    • Drive product certifications across development teams, testing labs suppliers and manufacturing partners

    • Compile data and write reports regarding existing and potential engineering studies and projects

    • Prepare and/or edit test procedures used during design and manufacturing processes that affect safety/compliance testing.

    • Facilitate safety reviews of products, systems and/or components as part of new product development, and modify / update existing products

    • Participate and/or lead cross-functional teams to address product compliance related issues

    • Define and oversee the hardware certification test requirements and validate testing reports for accuracy, completeness, and ensure all mandatory requirements are properly accounted for in complete package

    • Support environmental compliance for RoHS, WEEE, REACH and Prop65




    • Bachelor's Degree in Engineering or related field from an accredited university or college

    • Minimum of 4 years of compliance (safety or EMC) engineering experience

    • Experience with working with test labs, updating technical files, and obtaining agency approvals

    • Experience working in a regulated industry, FDA preferred

    • Experience certifying WiFi/Wireless products is a plus

    • Hands-on testing experience for EMC/EMI/RF exposure regulatory compliance for FCC/ISED

    • Attentiveness to details with strong organizational skills

    • Ability to work proactively and independently

    • Excellent verbal communication and interpersonal skills with the ability to work in a team environment

    • Track record of developing new skills quickly and cross-pollinate the learnings from one area to another.

    • Ability and willingness to dig deeper, take the ownership of the issue on hand and make a meaningful contribution towards investigation and resolution of the issue.



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