design-reviews 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.…See more 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.

Senior System Engineer responsible for leading systems engineering activities across complex hardware, software, and integrated systems. Plans and executes risk assessments, hazard analyses, design reviews, system integration, and verification/validation strategies while serving as a technical leader on project core teams.…See more Mentors junior engineers, drives continuous improvement initiatives using Design for Six Sigma (DFSS) methodologies, and facilitates cross-functional collaboration across Reliability, Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, Clinical, and Operations teams. Requires 3–5+ years of engineering experience, strong systems thinking, requirements management expertise, and demonstrated leadership in complex product development.

This role supports the full product lifecycle for complex integrated systems, focusing on requirements management, system integration, verification & validation, and risk management. The Systems Engineer will conduct FMEA and hazard analysis, collaborate across software, electrical, mechanical, quality, and regulatory teams, and drive activities from concept through launch.…See more The position requires 3+ years of systems engineering experience, a bachelor's degree in engineering, and expertise in requirements traceability and risk assessment.

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.…See more 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.

Lead cross-functional engineering development programs spanning mechanical, electrical, photonics, software, and firmware teams at a quantum hardware startup. Drive day-to-day execution, manage scope/schedule/budget for photonics hardware projects, identify risks, unblock teams, and partner with supply chain to ensure on-time delivery.…See more Requires a Ph.D. in engineering and minimum 8 years of hardware project engineering or hardware product management experience, with proven ability to execute structured hardware development processes across multiple disciplines.

Lead a mobile engineering team building iOS and Android applications for an Automated Insulin Delivery system and diabetes management platform. Manage developers proficient in Kotlin, Swift, Objective-C, and Flutter; drive technical architecture, code quality, and design reviews; collaborate with systems engineering, clinical, and quality teams to deliver regulated medical device software.…See more Requires 5+ years of relevant experience (or 3+ with an advanced degree), strong debugging and problem-solving skills, and ability to coach developers on software principles and best practices.

Senior Systems Engineer responsible for leading systems engineering activities on complex medical device and integrated products at BD. The role requires developing and executing reliability planning, driving cross-functional collaboration across engineering disciplines, investigating and resolving system performance issues, and mentoring junior engineers.…See more The position demands expertise in requirements management, system verification/validation, risk management (FMEA, hazard analysis), Design for Six Sigma methodologies, and model-based systems engineering, with 3-5+ years of relevant engineering experience and a strong technical background.

Systems Engineer responsible for translating market and user needs into clear requirements across biology, hardware, and software subsystems at an early-stage cell-therapy manufacturing startup. Owns requirements management, interface control documentation, and system block diagrams to keep multiple engineering teams aligned during prototype development.…See more Leads verification, validation, and risk analysis planning; supports design reviews and regulatory compliance through design history file maintenance. Expects hands-on involvement in prototype assembly, testing, and cross-disciplinary problem-solving in a research-to-product transition environment.

Senior Systems Engineer responsible for leading system integration planning, verification and validation strategy, and reliability engineering for complex medical devices or integrated systems at BD. Own cross-functional coordination across Reliability, Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Clinical teams while investigating system-level issues, managing technical risks (FMEA, hazard analysis), and mentoring junior engineers.…See more Develop requirements, drive design reviews, and apply Design for Six Sigma (DFSS) methodologies to enhance product quality and development efficiency from concept through commercialization.

The Systems Engineer applies systems engineering discipline to define, develop, integrate, and test complex in vitro diagnostic medical devices. Responsibilities include capturing user requirements, authoring system and subsystem requirements documentation, conducting hazard and risk analysis, managing configuration and change control, driving system integration and root-cause analysis, and coordinating with development, testing, clinical, and cross-functional teams.…See more The role requires a BS in engineering, 10+ years of industry experience, proven medical device development background, and proficiency in systems engineering methodologies including requirements decomposition, architecture, design reviews, and risk management.

This Systems Engineer role at a medical device company requires decomposing regulatory and stakeholder requirements into testable system specifications, leading design reviews and verification/validation activities, and supporting risk management under FDA and ISO frameworks. The position demands 2+ years in a regulated medical device environment, with responsibility for traceability documentation, design history files, failure investigation, and CAPA activities.…See more Key competencies include FDA design controls, ISO 14971 risk management, human factors/usability per FDA guidance, and cross-functional communication of complex system interfaces to diverse audiences.

Hardware Engineering Manager who establishes technical direction, engineering standards, and design practices across the hardware development lifecycle. The role balances organizational effectiveness, staffing, and execution health while partnering with Principal Engineers on discipline-level technical leadership.…See more Responsibilities span concept through production, including design reviews, technical risk management, electro-mechanical integration, military/industry standards compliance, and cross-functional collaboration with systems, software, production, and supply chain teams. Requires 8+ years developing complex hardware or electro-mechanical systems and proven experience leading engineering teams.

Lead a hardware engineering team to establish technical direction, engineering standards, and design practices across the full product lifecycle from concept through production. Own organizational effectiveness, staffing, and execution health while partnering with Principal Engineers on discipline-level technical leadership.…See more Drive hardware development excellence through electro-mechanical integration, design reviews, and continuous process improvement. Balance resources across customer programs, internal product development, and sustaining engineering while collaborating with Systems Engineering, Software, Production, Quality, and Supply Chain.

Director/Principal Engineer leading all technical aspects of automotive software programs with OEM customers, including Cockpit (IVI) and ADAS initiatives. Responsibilities span technical leadership of SoC, platform software, tools, and system integration; program execution across concept through SOP and maintenance phases; and serving as the primary technical liaison between customer engineering executives and Qualcomm's internal teams.…See more The role requires coordinating cross-functional engineering workstreams (hardware, software, systems, safety, security, tools, test), driving resolution of critical technical issues, and translating customer needs into platform requirements and solutions.

Lead a mobile engineering team building Flutter and native iOS/Android applications for an Automated Insulin Delivery (AID) medical device ecosystem. Manage developers proficient in Kotlin, Swift, and Objective-C while collaborating with systems architects, quality teams, and cross-functional stakeholders to deliver robust, secure mobile apps in a regulated healthcare environment.…See more Provide technical direction, conduct design reviews, coach team members on software development principles, and drive product quality through agile/scrum practices.

This Systems Engineer role at General Atomics involves preparing and executing program milestone reviews (SRR, SFR, PDR, CDR, TRR, AR), developing systems engineering documentation and contract deliverables, and supporting requirement verification using MBSE models and DOORS. The engineer will interface with customers during program shaping and requirements derivation, provide direction to technical staff, and resolve complex engineering problems.…See more The position requires a bachelor's degree in engineering (or master's with less experience) plus progressive experience applying engineering principles, MBSE/SysML tools, and systems engineering processes including risk and change management.