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.

     

    Responsibilities:

     

    • 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

     

    Qualifications:

     

    • 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.

     

     

    Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf