Senior Quality Engineer, Structural Heart Valve

Capstan Medical; Santa Cruz (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

100% medical, dental, and vision coverage for employees and their families

Flexible time off

Collaborative work environment

Job summary

Capstan Medical is seeking a Quality Engineer to support the mitral and tricuspid structural heart valve product line. The role focuses on design controls, risk management, and ensuring compliance with regulatory standards.

This position requires collaboration with R&D and manufacturing, as well as experience in quality engineering for medical devices. Benefits include comprehensive medical coverage and a vibrant work environment.

Qualifications

• 5+ years of quality engineering experience in medical devices, especially implantable and sterile devices.
• Experience with design controls and risk management.
• Familiarity with ISO and FDA regulations.

Responsibilities

• Support design controls, risk management, and manufacturing readiness.
• Implement acceptance activities related to product quality.
• Lead continuous improvement activities and audits.

Skills

Medical device quality systems

Sterile medical device processes

Microbiology test methods

Problem-solving skills

Cross-functional communication

Education

Bachelor's degree in Engineering, Life Sciences, Microbiology or related field

Job description

Capstan Medical is seeking a Quality Engineer to support the mitral and tricuspid structural heart valve product line. The role focuses on design controls, risk management, and ensuring compliance with regulatory standards.

This position requires collaboration with R&D and manufacturing, as well as experience in quality engineering for medical devices. Benefits include comprehensive medical coverage and a vibrant work environment.