Senior Manufacturing Engineer, Component Engineer

Capstan Medical; Emeryville (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

100% medical, dental, and vision coverage

Flex time off

Collaborative work environment

Job summary

Capstan Medical is seeking a Senior Manufacturing Engineer to lead the production process for innovative medical technology. This role demands a collaborative and hands-on approach in a dynamic environment focused on minimally invasive heart valve treatment.

With over 5 years of engineering experience, you will be integral in developing manufacturing processes, troubleshooting production issues, and ensuring quality standards. Join us to contribute to transformative healthcare solutions.

Qualifications

• 5+ years of experience in manufacturing engineering.
• Strong background in component engineering.
• Experience in regulated industries is preferred.

Responsibilities

• Own manufacturing process development for Capstan accessories.
• Lead investigations for component-related nonconformances.
• Collaborate with suppliers to resolve quality issues.

Skills

Manufacturing engineering

Component engineering

Supplier quality resolution

Electromechanical assemblies

Process validation

Education

Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering

Job description

At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands‑on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.

Based in Santa Cruz, our unique workspace blends cutting‑edge Bay Area innovation with a lifestyle‑driven environment near trails, beaches, and open space—creating the perfect place to do meaningful, career‑defining work.

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.

Manufacturing Support & Process Development

• 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.

Component Engineering & Nonconformance Ownership

• 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.

Supplier Partnership & Cross‑Functional Execution

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

Required Qualifications

• 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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.