Sr. Software 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. 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 seeking an experienced Sr. Software Engineer to participate in the Software Development Lifecycle of embedded application software in an established engineering organization. The Sr. Software Engineer will collaborate with multiple engineering disciplines and other stakeholders to deliver robust, 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.
Responsibilities, Skills & Hands-On Experience:

• Generate and execute development plans ensuring alignment with project goals and schedules.
• Contribute to the design, implementation and documentation of embedded application software.
• Author and maintain software requirements based on user and product-level requirements.
• Develop and validate software unit tests for new software features.
• Identify, document, and investigate software anomalies in both application software and device firmware.
• Support regulatory submissions and responses, including the generation of technical documentation and justifications.

Preferred Skills & Hands-On Experience:

• Demonstrated ability to develop embedded software using C/C++.
• Experience developing Windows based applications required, with experience on other platforms a plus.
• Excellent communication skills with the ability to clearly communicate with Engineering, Quality, Regulatory and other stakeholders.
• Proven experience with formal software lifecycle processes, version control (e.g., Git), static analysis, code statement coverage and automated testing tools.
• Strong knowledge of IEC 62304, ISO 14971, FDA 21 CFR Part 820, and the FDA guidance on General Principles of Software Validation.

Education & Work Experience:

• Bachelor’s or Master’s degree in Computer Science, Computer Engineering, or related discipline.
• 7+ years software development experience in the medical device industry.
• Working knowledge of Qt application framework a plus.

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 $145,000 - $175,000 + 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 hr@shifamed.com.