Senior Manufacturing Engineer, Component Engineer

Capstan Medical, Inc. • Santa Cruz, CA

13d

About The Position

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.

Requirements

• 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

Responsibilities

• 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

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: Senior