Medtech Manufacturing Engineer II Implant Process & Tools

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

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.