Director, Software Engineering

Shifamed•Los Gatos, CA

13h•$210,000 - $240,000•Onsite

About The Position

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. To learn more about Supira Medical, please visit www.supiramedical.com. 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: We are currently looking for a hands-on Director, Software Engineering interested in developing a medical device in a fast-paced startup environment. In this role, you will oversee embedded software architecture, direct security strategy (in partnership with third-party consultants), and drive excellence in software development planning and process. You will collaborate closely with clinical, hardware, quality, regulatory affairs, and engineering teams to deliver high-integrity, compliant, and secure solutions that meet both regulatory requirements and clinical needs. This is a full time, on-site position and will require reporting to our offices located in Los Gatos, CA.

Requirements

Experience managing medical device software development from concept through regulatory approval.
Experience managing multiple simultaneous development projects with geographically diverse teams.
Familiarity in full stack development with C++ and Qt for medical device applications.
Working knowledge/experience with cloud security and security certifications
Familiarity with user management, authentication, and authorization frameworks.
Strong verbal and written communications, and presentation skills.
BS in CE, CS or a related discipline.
Minimum 12 years of relevant experience, including 5+ years of technical management responsibilities with medical device technologies.
Proficiency in programming using C++, C and Python, and experience with OOP design.
Proven project management experience on large software projects with hardware components and real time systems
Experience with a class III medical device company.
Experience in a venture-funded startup environment.

Nice To Haves

Experience with development of GUIs used in a clinical setting.
Experience with “Software as a medical device”
Experience with development of real-time embedded controls for a medical device.
Advanced degree in an engineering discipline.

Responsibilities

Manage internal and external software development.
Provide direct software development contribution.
Develop budgets and project plans.
Develop design specifications based on top-level product requirements.
Develop and implement software compliance policies and procedures, including with respect to IEC 62304, FDA guidance, HIPAA, cybersecurity and GDPR requirements.