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 Sr. Software System Verification Engineer interested in planning, developing and executing software verification, and supporting networked equipment, in a fast-paced startup environment. Responsibilities, Skills & Hands-On Experience: - Leads the development and execution of system verification plans for medical devices, ensuring compliance with all relevant regulations (e.g., FDA, IEC 61010, ISO 14971, IEC 62304). Analyze system requirements and translate them into test protocols.
- Designs and implements test strategies and methodologies for various system components and functionalities across the Software, Hardware, and Systems levels.
- Develops and maintains automated test scripts using appropriate tools and languages (e.g., Python, C++, Java, Qt Squish, and other test frameworks).
- Performs manual testing and analysis to identify and document potential issues and defects.
- Coordinates with project management on verification timelines and readiness.
- Collaborates effectively with cross-functional teams (e.g., engineering, software, quality, Systems) to resolve identified issues and ensure timely closure.
- Participates in risk assessments and failure mode analysis (FMEA) to identify and mitigate potential risks.
- Maintains accurate and complete documentation of all verification activities, including test plans, reports, and defect tracking.
- Contributes to engineering discussions regarding design for testability, maintainability, and quality.
- Ensures alignment of internal and external customers.
- All other duties, as assigned.
Preferred Skills & Hands-On Experience: - Develop, manage, and drive the end-to-end testing of all components and features of the application under test.
- Collaborate with stakeholders to define test objectives, assess testing scope, and formulate functional and non-functional test strategies, plans, and artifacts.
- Develop comprehensive test cases for product requirements. Create and manage test epics, user stories, test tasks, test cases, and defects within sprint cycles.
- Make sure that components and features work as per the functional requirement document.
- Analyze and deliver test progress reports for sprints and builds.
- Develop automated test cases.
- Analyze the requirements and create continuous integration and deployment solutions for automated testing.
- Create automated test cases, integrate test data, and deploy solutions.
- Create testing artifacts such as test strategy, test plan, test cases, test data, requirement traceability matrix, test coverage matrix, test scripts, defect report, test closure report etc.
- Participate in requirement discussions with systems group.
- Partner with cross-functional team to ensure all areas of the application are fully covered and issues are clearly tested and logged in and prioritized.
- Ensure all non-functional requirements such as performance, scalability, security, usability, etc. are met.
Education & Work Experience: - BS in Computer Science, Biomedical/Mechanical Engineering or directly related scientific discipline.
- Applied understanding of Firmware, Software, Internet, Electromechanical, and Systems design.
- 7+ years of experience in System testing and 5+ years of experience in medical device engineering or a related role.
- Solid understanding of medical device regulations and standards (e.g., FDA QSR, ISO 13485, IEC 62304, and IEC 60601).
- Proficiency in system-level design, requirements management, and architectural development.
- Excellent working knowledge of computer systems including MS Office Suites with advanced knowledge of Excel.
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 $130,000 - $160,000 + 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.
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