Senior Manufacturing Engineer, MedTech Implants & Scale-Up

Capstan Medical, Inc.; Santa Cruz (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Capstan Medical, based in Santa Cruz, is building a robotic platform for minimally invasive heart valve treatment. We seek a Senior Manufacturing Engineer to lead development and productization across the size matrix, from early design input through transfer and launch.

You will scale processes, design fixtures, drive DFM input with R&D, manage multiple parallel builds, and ensure quality and compliance with ISO 13485 and 21 CFR 820.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field.
• Minimum 5 years of relevant experience in a medical device manufacturing environment, including new product development and design transfer.
• Hands-on experience taking a product from development builds through validation and into production.
• Familiarity with ISO 13485, 21 CFR 820, and ISO 14971.

Responsibilities

• Own manufacturing development for new implant sizes, from early design input through design transfer and production release.
• Scale existing implant processes, tooling, and documentation across the size matrix, identifying size-dependent risks early.
• Provide DFM input to R&D during design and design reviews, and influence designs for manufacturability, yield, and cost.
• Design, qualify, and release size-specific fixtures, mandrels, and tooling for forming, assembly, loading, and inspection.
• Plan and execute engineering, verification, and clinical builds for new sizes in partnership with R&D, Quality, and Operations.
• Lead process characterization and validation (IQ/OQ/PQ, TMV) and apply DOE and statistical methods to set robust process windows.
• Author and maintain PFMEAs, process flows, MPIs, DHRs, and inspection procedures for new product introductions.

Skills

Communication

CAD

PFMEA

DOE

SPC

Problem-solving

Education

Bachelor’s degree in Mechanical Engineering

Job description

Capstan Medical, based in Santa Cruz, is building a robotic platform for minimally invasive heart valve treatment. We seek a Senior Manufacturing Engineer to lead development and productization across the size matrix, from early design input through transfer and launch.

You will scale processes, design fixtures, drive DFM input with R&D, manage multiple parallel builds, and ensure quality and compliance with ISO 13485 and 21 CFR 820.