Manufacturing Engineer, Delivery System

Capstan Medical is an engineering incubator targeting early‑stage medical device design. We focus on cultivating cutting edge technology centered on patient value. Our team is highly collaborative and hands‑on, takes pride in iterating quickly, and believes that the best ideas can come from anywhere or any person! We always have multiple programs in the pipeline, so as a small team, we tend to wear multiple hats on a daily basis.

Capstan Medical is uniquely positioned in Santa Cruz, which we have chosen to be geographically close‑to but intentionally separate from the greater SF Bay Area. This gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is located in a repurposed warehouse space that used to be the Wrigley Gum factory, now the funky/diverse home to several bicycle companies, many art and architecture studios, a maker space, and several biotech startups.

It is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.

Currently, our active programs at Capstan Medical target catheter‑based, repair devices for diseases that affect the heart. These kinds of devices present patients with compelling, minimally invasive alternatives to traditional surgical methods. For most patients, this means less pain after surgery and being able to return to normal life much more quickly. For many older patients, reducing surgical trauma can make the difference between life and death.

Our current strength is in micro‑scale mechanical medical devices on the cutting edge of medicine but we are constantly evolving. The team has a collective background designing a wide variety of medical devices including cardiac devices, catheter‑based devices, collapsible implants, surgical tools and robotic systems.

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.

• 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

• 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 Solid Works 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

We offer a fun, hands‑on, fast‑paced, collaborative environment where you will be working on…