Manufacturing Engineer, Delivery System

Capstan Medical, Inc. • Santa Cruz, CA

11d

About The Position

The Manufacturing Engineer, Delivery System is responsible for developing, improving, and supporting scalable manufacturing processes for delivery system production. This role ensures product quality, operational efficiency, and regulatory compliance in a fast-paced, highly regulated environment.

Requirements

• Process Development & Optimization – Ability to design, document, and refine scalable manufacturing processes for medical devices.
• Validation Expertise – Skilled in writing and executing IQ/OQ/PQ protocols for equipment and processes.
• CAD & Engineering Tools – Proficient in tools like SolidWorks or AutoCAD for fixture/tooling design.
• Root Cause Analysis – Experience with 5 Whys, Fishbone Diagrams, and other RCA methods.
• Assembly Techniques – Familiarity with precision assembly, especially under a microscope, and bio-compatible material handling.
• Fixture & Equipment Design – Ability to design and troubleshoot jigs, fixtures, and semi automated equipment.
• Document Control – Ability to work within a QMS and manage engineering change orders (ECOs).
• Problem-Solving – Resourceful and proactive in identifying, analyzing, and resolving manufacturing issues.

Responsibilities

• Support and optimize manufacturing processes for the current generation delivery catheter system, including assembly, bonding, gluing, laser welding, and testing.
• Lead equipment selection, tooling development, and fixture design to enable efficient and repeatable production.
• Create and maintain manufacturing documentation, including work instructions, process flow diagrams, PFMEAs, and validation protocols (IQ/OQ/PQ).
• Execute and support process validation activities to ensure compliance with FDA and ISO 13485 requirements.
• Drive root cause investigations and implement CAPAs to support continuous improvement and nonconformance resolution.
• Support pilot builds, clinical manufacturing, and scaling to commercial production.
• Participate in design reviews, DFM/DFA discussions, and risk assessments.
• Contribute to the selection and management of external suppliers, contract manufacturers, and test labs.

Benefits

• We offer a fun, hands-on, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
• We offer projects and training to continue your learning and technical growth.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
• We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed