Manufacturing Engineer II - Implant

Lever, Inc.; Santa Cruz (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Capstan Medical, based in Santa Cruz, is developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. The team collaborates across R&D, Quality, and Operations to design, validate, and scale production processes for new implant sizes.

The role focuses on supporting development and transfer of new implants, improving fixture tooling, and ensuring compliance with GMP, ISO 13485, and 21 CFR 820. The environment blends advanced engineering with hands-on floor support.

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field
• Minimum 2 years of relevant medical device/manufacturing experience 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: Class III implants/heart valves, cleanroom micro-assembly, or biological material handling

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 and flag size-dependent issues
• 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 statistics
• 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

Validation

CAD & Fixture Design

Root Cause Analysis

Assembly Techniques

Document Control

Communication

Education

Bachelor's degree in Mechanical/Manufacturing/Biomedical Engineering or related field

Tools

SolidWorks

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