Supira Medical a clinicalstage Shifamed Portfolio Company is developing a lowprofile 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. To learn more about Supira Medical please visit . 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 Senior Quality Engineer will proactively drive quality and compliance in design and development 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 test method and process validation design controls design history file risk management design verification and process validation protocols and testing. This position also provides technical support to Operations and R&D groups. This position will also play an active role in the development and maintenance of the quality management system and ensure QMS compliance adherence. This is a full time onsite position and will require reporting to our offices located in Los Gatos CA. Responsibilities Skills & HandsOn Experience - Drive both test method and process validations including IQ/OQ/PQ for new and existing processes and test methods. Maintain the Master Validation Plan/Report.
- Support design transfer activities.
- Collaborate closely with crossfunctional teams including Operations/Manufacturing and R&D.
- Provide technical guidance and mentorship to junior engineers to cultivate a collaborative work environment.
- Support design controls deliverables including but not limited to DHF design verification documentation and risk management documentation.
- Support development and maintain risk management file and associated deliverables such as PFMEA and hazard analysis.
- Excellent communication skills: ability to work both independently and in project team setting.
Education & Work Experience - B.S. or higher in Biomedical Electrical Mechanical or Systems Engineering or equivalent relevant work experience.
- 5 years of experience in a quality engineering role. Experience in the medical device industry with electromechanical products and/or interventional cardiology products is preferred.
- Experience with Design Controls and Risk Management for medical device and/or interventional cardiology products.
- Proficiency and/or exposure to test method validation process validation and Design Verification including statistical techniques and data analysis.
- Working and demonstrated knowledge about medical device regulations including FDA QSR 13485 EU MDR etc.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your jobrelated knowledge skills experience relevant education and training/certifications. In addition to those factors we also examine internal equity as well as consider current market rate and title may be assessed one level lower or higher accordingly. After you join the company your performance contributions and results along with business and organizational needs will affect your base salary. The base salary range for this fulltime position is between $90000 to $180000 equity benefits. NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to
| Required Experience:
Senior IC