About this opportunity
Capstan Medical, Inc. lists this Manufacturing Engineer II - Implant opportunity in aptos, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Description 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.
Responsibilities & Skills: Key Responsibilities:
Support manufacturing development of new implant sizes, from engineering builds through design transfer and production release
Adapt existing implant processes, work instructions, and tooling to new sizes, flagging size-dependent issues to the team
Provide DFM/DFA feedback to R&D during design reviews and development builds
Design, build, and qualify size-specific fixtures and tooling for assembly, loading, and inspection
Plan and execute engineering, verification, and clinical builds with R&D, Quality, and Operations
Draft and execute process characterization and validation protocols (IQ/OQ/PQ, TMV), using DOE and statistical tools to analyze results
Draft and revise MPIs, DHRs, PFMEAs, inspection procedures, and engineering change orders for new product introductions
Support supplier onboarding for new-size components, including first article inspections
Train technicians/operators on new processes and support builds on the floor
Investigate process and component NCRs and support root cause and corrective actions
Skills:
Process Development - Ability to develop, document, and refine manufacturing processes for medical devices
Validation - Experience writing and executing IQ/OQ/PQ protocols
CAD & Fixture Design - Proficient in SolidWorks or similar 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 biocompatible material handling
Document Control - Ability to work within a QMS and manage DCNs
Excellent communication, documentation, and problem-solving skills, with the ability to manage multiple priorities
Requirements: Requirements:
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field
Minimum 2 years of relevant experience in a medical device or regulated manufacturing environment, with exposure to new product development or design transfer
Working knowledge of GMP, 21 CFR 820, and ISO 13485
Experience with validation (IQ/OQ/PQ), risk management (FMEA), and statistical tools (Minitab, JMP)
Preferred: experience with Class III implants or heart valves, cleanroom micro-assembly, or biological material handling
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. 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.
Worksite address
aptos, CA, 95003, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.