regulated-product-development jobs in San Diego

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.

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.