Staff Mechanical Engineer - Process Development

CompetitiveSan Diego United StatesStaff Mechanical Engineer - Process DevelopmentSan Diego, CA | On-siteHelp develop the next generation of medical devices.We're partnering with an innovative medical technology company developing a first-in-class drug delivery platform. They are looking for an experienced Mechanical Engineer to support the development, design transfer, and manufacturing scale-up of a groundbreaking Class III combination product.What You'll DoDevelop, optimize, validate, and scale manufacturing processes for an innovative medical device.Lead design transfer activities, including manufacturing methods, work instructions, inspection strategies, and process documentation.Collaborate with R&D, Manufacturing, Systems Engineering, Test Engineering, and Preclinical teams to improve device performance, manufacturability, and clinical readiness.Drive Design for Manufacturability (DfM) and Design for Assembly (DfA) initiatives.Support process characterization, DOE studies, root cause investigations, and continuous improvement projects.Contribute to risk management activities, including DFMEA/PFMEA, while ensuring compliance with FDA and ISO 13485 requirements.Provide technical leadership during engineering builds, process development, and clinical manufacturing.What We're Looking ForBachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.5+ years of experience developing Class II or Class III medical devices.Strong background in process development, design transfer, manufacturing engineering, and DfM.Experience with DOE, FMEA, statistical analysis, and process validation.Proficiency with SolidWorks and mechanical design for precision components.Knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device design controls.Experience with precision assemblies, injection molding, tooling, or drug-device combination products is highly desirable.A hands-on engineer who thrives in a fast-paced, collaborative product development environment.What's on OfferOpportunity to work on a first-in-class medical device with significant patient impact.Collaborative, highly innovative engineering team.Competitive compensation and comprehensive benefits package.Strong career growth opportunities within a rapidly expanding organization.If you're passionate about bringing innovative medical technologies from development into manufacturing, we'd love to hear from you.