Quality Engineer – Structural Heart Valves & Sterilization

Capstan Medical Inc.; Santa Cruz (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Flexible time off

Bike-friendly office

Job summary

Capstan Medical, based in Santa Cruz, is developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. The Quality Engineer will partner with R&D, Operations, Regulatory Affairs and Quality to ensure design controls, sterilization, and release processes meet regulatory expectations.

This role demands hands-on collaboration, strong problem-solving, and the ability to translate complex requirements into practical test methods and quality records, across

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Microbiology, or related field.
• 5+ years in quality engineering for medical devices.
• Experience with design controls, risk management, DHF/DMR documentation, and product/process changes.
• Experience with sterilization validation and microbiology testing.

Responsibilities

• Represent quality engineering for structural heart valve products, supporting design controls and release.
• Apply ISO 5840 knowledge to verify requirements and validation strategies.
• Support liquid chemical sterilization and related microbiology testing activities.
• Assist in establishing acceptance tests, sampling plans, and quality records.
• Support cleanroom operations, line readiness, and finished goods release.
• Lead or support NCR, CAPA, audits, and continuous improvement activities.
• Create and improve SOPs and quality records related to product quality and sterilization.

Skills

Quality systems

Design controls

Risk management

NCR/MRB/CAPA

Regulatory knowledge

Data analysis

Cross-functional communication

Education

Bachelor's degree in Engineering or related field

Tools

DHF/DMR documentation

Sterilization validation methods

Job description

Capstan Medical, based in Santa Cruz, is developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. The Quality Engineer will partner with R&D, Operations, Regulatory Affairs and Quality to ensure design controls, sterilization, and release processes meet regulatory expectations.

This role demands hands-on collaboration, strong problem-solving, and the ability to translate complex requirements into practical test methods and quality records, across