The Senior Scientific Platform Engineer will develop and maintain software components, data processing workflows, and platform services that operationalize scientific innovations for clinical studies. The role requires translating research outputs and algorithms into production-grade backend services, APIs, and data pipelines on AWS, while collaborating with Science, Data Science, Product, and Engineering teams.… The ideal candidate has 5+ years building analytics platforms or scientific computing solutions, strong Python proficiency, and experience with cloud-native and serverless architectures. The position demands the ability to understand complex scientific methods and transform them into scalable, validated, maintainable software solutions within a regulated healthcare environment.
iso-13485 jobs in San Diego
Staff QA Engineer at Dexcom leading manufacturing quality and regulatory compliance for continuous glucose monitoring devices. Responsibilities include directing Design Control and design transfer strategy, managing process validation and commercialization, leading cross-functional teams on complex technical and compliance matters, and providing expert guidance on Quality Management System governance (FMEA, CAPA, process controls).… Requires deep hands-on experience with FDA 21 CFR 820, ISO 13485, and related QMS requirements, plus ability to mentor teams and represent the organization during audits and regulatory inspections.
This is a hands-on product security role focused on threat modeling and cybersecurity risk management for medical devices and SaMD platforms. You'll conduct security risk assessments, build FDA submission documentation (510(k) files, risk management files, SBOMs), review security architecture, and maintain risk and vulnerability management plans.… The role requires 5+ years of cybersecurity or product security experience, with strong preference for FDA documentation and regulated medical device background, and working knowledge of NIST frameworks, OWASP, and secure SDLC practices.