Staff Mechanical Engineer - Process Development

San Diego, CA | On-site

Help 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 Do

• Develop, 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 For

• Bachelor'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 Offer

• Opportunity 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.