Senior Systems Engineer responsible for defining and maintaining system-level architectures for complex medical devices, including interface control documentation across fluidic, mechanical, electronics, software, and human factors subsystems. The role involves modeling system behavior using functional modeling techniques (SysML, functional block diagrams, state machines), conducting trade studies, and validating architectural assumptions through testing and characterization.… Requires partnering with cross-functional engineering teams to ensure subsystem alignment, supporting design controls per 21 CFR 820.30 and ISO 13485, and mentoring engineers on systems thinking and interface definition. This is a hands-on role grounded in bench-top testing, data analysis, and evidence-based architectural decisions rather than paper-only work.
design-controls jobs in San Diego
This role leads quality engineering strategy and operations for a medical device design center, overseeing compliance with FDA regulations (21 CFR 820, ISO 13485, ISO 14971) and managing a team of Quality Engineers. The manager develops and sustains quality management systems, executes quality initiatives, provides statistical and design-control expertise, and drives continuous improvement.… The position requires ten years of progressive QA experience in FDA-regulated industries, three years of direct management experience, and deep knowledge of design controls, risk management, and quality engineering methodologies.
Sr. Software QA Engineer responsible for ensuring medical device software products meet regulatory requirements and quality standards throughout the development lifecycle.… Reviews design control deliverables, risk management documentation, verification and validation activities, and software anomalies for compliance with FDA, ISO, and company procedures. Participates in design reviews, traceability analysis, CAPA investigations, and process improvement initiatives while supporting audits and regulatory inspections.
Sr Staff QA Engineer at Dexcom leading Design Quality Engineering for material characterization, formulation science, and material-related risk management across product lifecycle. Responsibilities include establishing traceability between material attributes and device performance, leading qualification strategies for polymers, enzymes, reagents, adhesives, coatings, and membranes, applying ISO 14971 risk management, and partnering with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs.… Requires 8+ years in medical device, pharmaceutical, biotechnology, or combination product development with deep expertise in material characterization, analytical chemistry, and formulation development.
Sr Staff QA Engineer at Dexcom leads Design Quality Engineering for material characterization, formulation science, and material-related risk management across product development and lifecycle management. The role requires deep expertise in characterizing complex material systems (polymers, enzymes, reagents, adhesives, coatings, membranes) and establishing traceability between material attributes, manufacturing processes, and finished device safety/performance.… Responsibilities include driving risk-based decision making using ISO 14971, overseeing qualification strategies, partnering with R&D and regulatory teams, and representing Design Quality in design reviews, audits, and regulatory submissions. Requires 8+ years in medical device, pharmaceutical, or biotechnology quality engineering with demonstrated experience in material characterization and design control processes.
Software Release Manager
ExpiredThe Software Release Manager owns end-to-end release planning, execution, and risk management for complex medical device software. The role requires technical understanding of system architecture and integration points to assess progress and anticipate risks, while coordinating across engineering, quality, regulatory, and product teams.… Responsibilities include managing schedules, budgets, vendor relationships, and ensuring compliance with FDA, ISO 13485, and IEC 62304 standards. The candidate will champion Agile and DevOps best practices, provide data-driven status reporting, and coach teams in hybrid Scrum environments.
Senior Software Engineer responsible for architecting and implementing complex Android applications in Kotlin for medical devices, with emphasis on reliability, security, and regulatory compliance. The role involves collaborating with embedded and systems engineers to integrate Bluetooth Low Energy (BLE) and other communication protocols with medical device hardware, designing testable architectures, and ensuring compliance with medical device standards like IEC 62304 and FDA requirements.… Responsibilities include leading design reviews, conducting root-cause analysis on field issues, implementing comprehensive testing strategies, and maintaining technical documentation for regulated environments.
Senior Embedded Software Engineer responsible for developing complex real-time embedded systems for electroporation therapy delivery, including firmware, device drivers, middleware, embedded UI applications, and system-level software. The role requires 7+ years of embedded software development experience with modern C++, ARM Cortex-M processors, RTOS frameworks (ThreadX, FreeRTOS, etc.), and expertise in real-time control systems, closed-loop feedback, safety-critical software, and cybersecurity implementation.… Responsibilities span architecture design, hardware-software integration, verification and validation, CI/CD support, and cross-functional collaboration with electrical, mechanical, and regulatory teams. The candidate must demonstrate proficiency with embedded development tools, debugging hardware, IEC 62304/IEC 60601 compliance standards, and FDA cybersecurity guidance.
Principal Systems Engineer
ExpiredPrincipal Systems Engineer leading full product development lifecycle for a Class II Medical Device, defining system architecture and engineering strategy across electrical, firmware, software, and manufacturing domains. Owns multidisciplinary systems end-to-end, establishing development processes (CI/CD, automated testing, version control), leading embedded hardware and firmware architectures, and ensuring FDA compliance and Design Controls adherence.… Serves as primary technical authority coordinating internal teams and external partners, conducting design/architecture reviews, supporting manufacturing scale-up, and mentoring cross-functional engineers. Requires 12+ years of multidisciplinary product development with demonstrated systems engineering expertise, regulated-industry experience, and technical leadership without direct authority.
Director-level role leading a software engineering team at a life sciences company building multi-omic analysis platforms. Requires hands-on full-stack expertise (React, Go, AWS, Temporal) alongside team management, architecture ownership, and end-to-end product delivery.… Must drive regulated software compliance (IEC 62304, ISO 13485, FDA 21 CFR Part 820), design controls, and V&V documentation while prototyping with AI tools and scaling agentic workflows within the team.
Director of Software Engineering leading end-to-end delivery across customer-facing products and internal tooling at a life-sciences company. This role combines hands-on full-stack development (React, Go, AWS, Temporal) with team leadership, architecture ownership, and regulated software compliance (IEC 62304, ISO 13485, FDA 21 CFR Part 820).… Candidates should have 10+ years of software engineering with 3+ years managing teams, fluency with modern AI coding assistants, and experience shipping instrumentation, cloud SaaS, and ML/AI features.
Lead the Sensor Technology workstream for Dexcom's Innovation, Ventures & Sensor Technology PMO, managing biosensing technology development from concept through product lifecycle. Own integrated program timelines, Work Breakdown Structure, and design controls compliance under 21 CFR 820 regulations.… Manage budget, resources, risk, documentation in the PLM system, and coordinate build/test activities while serving as the primary stakeholder liaison. This role requires significant medical device development expertise, strong project management skills across waterfall and hybrid methodologies, and preferably a technical background in Material Science or Electrochemistry.
Staff Technical Program Manager leading early-stage technology development projects within Dexcom's Innovation Ventures & Sensor Technology group. Oversees complex, cross-functional projects from concept through productization, managing project schedules, regulatory compliance, and technology risks while coordinating internal and external stakeholders.… Requires strong technical background in biomedical engineering, chemistry, or materials science with medical device development experience, particularly in sensor and algorithm development.
Lead software development for an FDA-cleared blood testing platform, overseeing instrument software, application software, cloud connectivity, cybersecurity, and software quality systems. Manage the full software development lifecycle including requirements, risk management, design controls, verification and validation, and regulatory compliance.… Work closely with Quality and Regulatory Affairs on FDA submissions, audits, documentation, and post-market support. Direct strategy, roadmap planning, architecture, and release management for a regulated in vitro diagnostic (IVD) medical device.