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10x Genomics · 13 hours ago

Senior Compliance Engineer (Contract Position)

Pleasanton, California, USA HQ

Contract

Onsite

Senior Level, Lead/Staff

10+ years exp

10x Genomics is committed to accelerating our understanding of biology and is seeking a highly motivated and experienced Senior Compliance Engineer. This role involves leading hardware and reagent compliance initiatives, interpreting regulatory requirements, managing product certifications, and collaborating with cross-functional teams to ensure compliance with various standards.

Biotechnology

H1B Sponsor Likely

Responsibilities

Collaborating with a cross-functional team to ensure compliance to regulatory requirements including UL, CSA, FCC, CE, KCC, SRRC, PSE, CB

Submitting official certification through relevant compliance bodies such as FCC, CE, UL, TUV, KCC, MIC, SRRC, etc. and acting as a liaison between 10x Genomics and state, local, federal and international agencies to submit required forms and paperwork while maintaining date and files for future reference, particularly in the event of an audit by a regulatory agency

Understanding RoHS, REACH, TSCA, Waste Electrical and Electronic Equipment (WEEE) Regulation and ensuring that new and existing products are designed to comply with those guidelines and tested accordingly

Determining and interpreting the relevant regulatory standards such as IEC 61010-1, IEC 61010-2-010, IEC 61010-2-081, IEC 60601 and how they apply to 10x Genomics products to establish and maintain guidelines and best design practices to mitigate compliance issues early in the design phase

Partner with R&D to ensure compliance with global EMC and EMI regulatory requirements, and working closely with electrical and systems engineering teams to define and implement design guidelines for shielding, grounding, and layout strategies to reduce emissions and improve immunity

Staying up to date with any changes to global agency approvals and testing procedures, as well as reviewing marketing, legal and technical documentation (for example: labeling user guides and declaration of conformity) to assess compliance with regularly reporting on compliance status and measures to both internal and external parties

Maintaining a deep understanding of new and existing regulation that may impact 10x Genomics products and processes and using that understanding to standardize all business operations and establish clearly documented protocols while explaining regulations, procedures and policies to all employees and stakeholders as necessary

Preparing Manufacturing site ready for the Regulatory Body audit for Product Safety Certification. Establishing a routine manufacturing test equipment Program for Hipot & Ground Bond testing, and managing bi-annual audits with external regulatory agencies for Product Safety Certification

Qualification

Regulatory complianceElectrical engineeringTechnical writingChemical complianceEnvironmental regulationsProject managementAudit preparationCompliance reportingCross-functional collaboration

Required

Minimum of Bachelor's degree in Electrical Engineering or related engineering field

Several years of experience and expertise in electrical engineering processes and procedures

10+ years of experience in regulatory compliance for hardware products, reagents, or both—preferably within the life sciences, diagnostics, or medical device industries

Familiarity with environmental regulations (RoHS, REACH, WEEE, TSCA, etc.) and how they apply to product design, component selection, and global distribution

Strong project management skills, with the ability to manage multiple regulatory timelines and interact with cross-functional teams (e.g., R&D, manufacturing, supply chain)

Excellent technical writing and documentation skills, including experience with compliance reports, regulatory submissions, and audit-ready file maintenance

Ability to interpret regulatory language and apply it practically to product development and compliance strategies

Preferred

Additional Experience with chemical and reagent compliance, including SDS authoring, GHS/CLP labeling, and familiarity with REACH, TSCA, and international chemical inventory regulations is strongly preferred

Company

10x Genomics

Glassdoor3.5

Cells are the basic unit of life.

Founded in 2012

Pleasanton, California, US

1001-5000 employees

http://10xgenomics.com

H1B Sponsorship

10x Genomics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (41)

2024 (40)

2023 (35)

2022 (52)

2021 (34)

2020 (16)