Senior Manufacturing Engineer, Component Engineer

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.

About the Role

We are seeking a Senior Manufacturing Engineer to play a critical role in scaling and sustaining production of Capstan accessories, including the Capital Controller and single-use devices. This role will also involve component engineering for the current generation Capstan Delivery System supporting component and supplier related issues.  

This is a hands-on, startup-style role for an engineer who is comfortable operating in ambiguity, moving quickly, and owning problems end-to-end while maintaining rigor expected in a regulated medical device environment.

• Own manufacturing process development and day-to-day production support for Capstan accessories, including Capital Controller and single-use devices.  
• Develop, characterize, and improve manufacturing processes to support rapid iteration and scalable production
• Create and maintain manufacturing documentation including work instructions, process flows, and build documentation
• Troubleshoot complex manufacturing and assembly issues on the floor with a strong bias to action

• Serve as the engineering owner for all component-level issues on current-generation Delivery System. 
• Lead investigations and root cause analysis for component- and supplier-related nonconformances (NCRs)
• Drive containment, disposition, and corrective actions in partnership with Quality, Supply Chain, and suppliers

• Work directly with suppliers to resolve quality, yield, and performance issues
• Collaborate closely with R&D, Quality, Operations, and Supply Chain

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline
• 5+ years of experience in manufacturing engineering, preferably in medical devices or regulated industries
• Strong background in component engineering and supplier quality issue resolution
• Hands-on production support experience
• Experience with electromechanical assemblies and single-use devices
• Familiarity with ISO 13485 and FDA QSR
• Experience with process validation, PFMEA, SPC

Why Join Us:

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.