Quality Engineer

Quality Engineer

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock.

ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description: 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. This position provides technical support to Operations and R&D groups. This position 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 and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience:

• Direct support of batch release testing and maintenance. Includes data analysis and interpretation.
• Responsible for oversight of batch release equipment including reviewing equipment calibration / preventive maintenance, and investigation and disposition of equipment events.
• Collaborate closely with cross-functional teams, including Operations and R&D.
• Support Operations including Nonconforming Materials Reports (NCMR) investigation, identifying appropriate corrective actions and disposition of material.
• Work closely with and provide technical guidance to quality technicians.
• Support design transfer and production support activities.
• Support development of risk management file and associated deliverables, such as PFMEA and Master Validation Plan.
• Excellent communication skills: ability to work both independently and in project team setting.
• Experience with electromechanical systems is preferred. Good attention to detail is required.

Education & Work Experience: B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience. 2+ years of experience in an engineering role. Experience in the medical device industry with electromechanical products and/or interventional cardiology products is preferred. Familiarity with the concepts of 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, 13485, EU MDR etc.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $95,000 to $120,000 + equity + benefits.

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