Quality Engineer

Supira Medical is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support during high risk percutaneous coronary interventional (HRPCI) procedures and for patients suffering from cardiogenic shock. The device will be used in clinical settings, including operating rooms and specially equipped procedure laboratories.

Our Quality Engineer will proactively drive quality and compliance in the production support area in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the design and development in early stages. As a key member of the team, you will actively support process validation, risk management, design verification and validation protocols and qualification for test equipment.

The role provides technical support to Operations and R&D groups and will also play an active role in the operation and maintenance of our key simulated use equipment.

This is a full time on‑site position that requires reporting to our offices located in Los Gatos, CA.

• Direct support of batch release testing and maintenance, including data analysis and interpretation.
• Oversee batch release equipment, reviewing calibration/preventive maintenance and investigating and disposing of equipment events.
• Collaborate closely with cross‑functional teams, including Operations and R&D.
• Support Operations through Nonconforming Materials Reports (NCMR) investigation, identifying appropriate corrective actions and material disposition.
• Provide technical guidance to quality technicians.
• Support design transfer and production support activities.
• Develop risk management files and associated deliverables, such as PFMEA and Master Validation Plan.
• Communicate effectively, working independently and as part of a project team.
• Preferably have experience with electromechanical systems; strong attention to detail is required.

• B.S. or higher in Biomedical, Electrical, Mechanical, or Systems Engineering, or equivalent work experience.
• 2–5 years of experience in an engineering role.
• Experience in the medical device industry with electromechanical or interventional cardiology products is preferred.
• Familiarity with test method validation, process validation, and Design Verification, including statistical techniques and data analysis.
• Experience with software is desired.
• Exposure to Risk Management for medical devices.
• Exposure to medical device regulations, including FDA QSR, ISO 13485, EU MDR, etc.

The base salary range for this full‑time position is between $95,000 and $120,000, plus equity and benefits.