Software Quality Test Engineer

Overview

About Shifamed

Description

, 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.

& Work Experience

• B.S. or higher in Computer Science, Software Engineering, Biomedical, Electrical, or related engineering field; or equivalent relevant work experience.
• 2-5 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 hr@shifamed.com.