Senior Data Engineer

Senior Data EngineerA venture-backed startup developing a novel wearable medical device is hiring a Senior Data Engineer. The company is running multiple clinical trials leading toward a pivotal FDA submission. This role owns the company's data architecture end to end and reports to the Director of Data Science.

The work starts upstream: you'll make sure the right data is collected in the first place by turning clinical, regulatory and commercial needs into instrumentation specs, then build the infrastructure that makes that data useful. It's hands-on. You'll design schemas and implement them, contribute to product concepts, and build several systems from scratch.

The data includes telemetry from embedded and mobile systems with intermittent connectivity, clinical outcomes, EDC data, and evolving manufacturing and production systems.Define what data to collect from the device, manufacturing and business operations, and translate those needs into instrumentation specs and data modelsDesign and own data schemas that serve analytical, regulatory and operational users, and document the tradeoffsBuild and maintain transformation pipelines on Google Cloud and BigQueryOwn the warehouse layer, including schema implementation, versioning, access controls and data quality monitoringKeep lineage and transformation logic traceable to a standard that holds up in a regulatory auditBuild integrations with EDC systems and third-party device dataProduce CDISC-compliant datasets (SDTM/ADaM) for regulatory submissionsBuild manufacturing data infrastructure: lot tracking, supply chain, process control and non-destructive testing recordsDefine data quality metrics and checks, own the fixes, and step into analysis when the team needs it7+ years of data engineering experience, with a track record of owning production data systems end to endExperience defining data models and instrumentation requirements upstream of pipeline developmentStrong Python and SQL, plus working knowledge of cloud data platforms (the stack is Google Cloud, BigQuery and Firestore)Strong data modeling skills, with the judgment to serve multiple users and make tradeoffs explicitExperience turning business and scientific requirements into specs across data science, engineering, operations, clinical and regulatory teamsClear, direct communication with non-technical stakeholdersExperience in a regulated industry (medical devices, pharma or clinical research) where auditability and traceability are requiredFamiliarity with CDISC (SDTM/ADaM) or clinical trial data formatsExperience with EDC systems such as Castor, REDCap, Medidata Rave or Veeva VaultExposure to 21 CFR Part 11Experience with manufacturing, supply chain or operational data systemsBackground in medical devices, wearables or digital healthMS in computer science, data engineering, biomedical informatics or a related fieldCandidates must be authorized to work in the U.S. without sponsorship and must live within commuting distance of San Diego.