Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.
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:
As the Sr. or Staff Software Quality Test Engineer on the Akura quality team, you will own software quality activities across the product lifecycle, with a focus on developing test cases, maintaining software requirements traceability, and executing and logging software verification testing for our thrombectomy platform. You will partner closely with software, systems, and R&D engineering to ensure our products meet quality, safety, and regulatory expectations under FDA Quality System Regulations, ISO 13485, ISO 14971, and IEC 62304.
Responsibilities, Skills & Hands-On Experience:
- Develop, review, and maintain software test cases derived from approved software requirements and design specifications.
- Assist in implementing automated testing software by creating the supporting documents and executing non-product software validation in accordance with Akura’s Quality System.
- Create and maintain the software Requirements Traceability Matrix (RTM), linking user needs, software requirements, design elements, risk controls, test cases, and test results.
- Execute software verification, integration, and regression testing per approved protocols; capture objective evidence (logs, screenshots, and recordings) and record results in the test management system.
- Author software test protocols, test reports, and test summary documents that meet IEC 62304 and design control expectations.
- Identify, document, and track software anomalies and defects to closure; participate in root cause analysis and verify fixes through targeted retesting.
- Support software risk management activities per ISO 14971, including review of software FMEA and traceability of risk controls to verification evidence.
- Contribute to the software portion of the Design and Development File (DDF), including configuration management records.
- Support software change control: assess proposed changes for regression risk, identify required regression test coverage, and execute regression testing.
- Participate in design reviews, code reviews, and software release readiness reviews, representing the quality perspective.
- Support internal and external audits (FDA, notified body, ISO 13485) by providing software verification records, traceability evidence, and test results.
- Initiate, support, and close CAPAs and NCMRs related to software issues; perform trend analysis on software complaints and post-market data.
- Help develop and continuously improve software quality SOPs, work instructions, templates, and test management practices.
- May perform other duties as assigned.
Education & Work Experience:
- B.S. or higher in Computer Science, Software Engineering, Biomedical, Electrical, or related engineering field; or equivalent relevant work experience.
- 7+ years of experience in software quality assurance, software test, or software verification; medical device industry preferred.
- Working knowledge of IEC 62304 (software lifecycle), ISO 14971 (risk management), FDA Quality System Regulations (21 CFR Part 820), and ISO 13485.
- Hands-on experience developing test cases, requirements traceability matrices, and test protocols/reports in a regulated environment.
- Familiarity with FDA guidance on software validation, premarket cybersecurity, and Software as a Medical Device (SaMD); exposure to AAMI TIR45 and IEC 81001-5-1 is a plus.
- Expertise in Jira/Xray for requirements and test management is required.
- Familiarity with embedded software, real-time operating systems, or electromechanical medical devices is a plus.
- Scripting or test automation experience (e.g., Python, pytest, Robot Framework) is a plus.
- Strong written and verbal communication skills; ability to author clear, traceable technical documentation.
- Ability to work both independently and in a cross-functional project team setting.
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.
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 [email protected].