{"id":3856682,"url":"https://alion.io/job/sunovaa-software-quality-engineer-medical-device-software","title":"Software Quality Engineer - Medical Device Software","company":{"id":3800722,"name":"Sunovaa","domain":"sunovaa.com","url":"https://alion.io/company/sunovaa-tech","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"QA","role_family":"QA","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Pune, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":".NET","optional":false},{"name":"Agile","optional":false},{"name":"Azure DevOps","optional":false},{"name":"C#","optional":false},{"name":"CI/CD","optional":false},{"name":"Cypress","optional":false},{"name":"Design History File","optional":false},{"name":"Git","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"JavaScript","optional":false},{"name":"Jira","optional":false},{"name":"Playwright","optional":false},{"name":"Rest API","optional":false},{"name":"Scrum","optional":false},{"name":"Selenium","optional":false},{"name":"TypeScript","optional":false},{"name":"Verification & Validation","optional":false},{"name":"Azure","optional":true},{"name":"Windows","optional":true}],"status":"live","first_seen_at":"2026-11-06T05:32:32Z","employer_posted_date":null,"last_verified_at":"2026-11-06T05:32:32Z","board_verified":false,"closed_at":null,"days_open":1,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":1},"description":"Role Summary:\n\nWe are looking for an experienced Software Quality Engineer (SQE) to drive Software Verification & Validation (V&V) activities for cloud services, edge applications, and platform solutions in a regulated medical-device software environment.\n\nThe role will focus on test planning, test automation, API and web testing, requirements traceability, defect management, release verification, and maintaining audit-ready quality documentation.\n\nKey Responsibilities:\n\n- Develop test strategies, test plans, test cases, and verification protocols.\n\n- Perform manual, exploratory, integration, system, regression, and end-to-end testing.\n\n- Review requirements, architecture, and user stories for completeness and testability.\n\n- Develop and maintain automated tests for APIs, backend services, web applications, system and command-line tools.\n\n- Develop automation using C#/.NET or TypeScript/JavaScript.\n\n- Work with Playwright, Cypress, or Selenium for web automation.\n\n- Integrate automated tests into CI/CD pipelines.\n\n- Analyze test failures and improve test coverage and automation reliability.\n\n- Manage end-to-end requirements traceability using Jama Connect.\n\n- Maintain traceability between Requirements, Risk Controls, Test Cases, Test Results, and Defects.\n\n- Prepare traceability matrices, coverage reports, test evidence, verification reports, and quality summaries.\n\n- Log, track, verify, and retest defects using Jira/Azure DevOps.\n\n- Perform regression impact analysis and root-cause investigations.\n\n- Support Test Readiness Reviews (TRR), release reviews, and phase-gate assessments.\n\n- Ensure audit-ready test documentation and approvals.\n\n- Collaborate with Development, Product, Architecture, Quality, and Regulatory teams in an Agile/Scrum environment.\n\nMandatory Skills:\n\n- 6+ years of Software Testing / Software Quality Engineering experience.\n\n- Strong experience in Software Verification & Validation (V&V).\n\n- Hands-on Test Automation experience.\n\n- Strong programming experience in C#/.NET OR TypeScript/JavaScript.\n\n- Hands-on experience with Playwright, Cypress, or Selenium.\n\n- Strong API / REST API testing experience.\n\n- Experience in manual, integration, system, regression, and E2E testing.\n\n- Strong understanding of SDLC/STLC.\n\n- Experience with CI/CD and Git.\n\n- Experience with Jira or Azure DevOps.\n\n- Experience working in Agile/Scrum.\n\n- Strong understanding of defect management and test documentation.\n\nMedical / Regulatory Experience Mandatory Priority:\n\n- Experience testing Medical Device Software / Healthcare Software.\n\n- Knowledge or hands-on experience with IEC 62304.\n\n- Knowledge of ISO 13485.\n\n- Knowledge of ISO 14971 / Risk Management.\n\n- Understanding of FDA/MDR software guidance.\n\n- Experience with requirements traceability and risk-based testing.\n\n- Experience supporting audits, DHF documentation, verification evidence, or regulatory submissions is highly preferred.\n\nPreferred Skills:\n\n- Jama Connect.\n\n- Cloud, distributed, or edge-based systems.\n\n- Cybersecurity testing and vulnerability verification.\n\n- Containers and networking.\n\n- Authentication and security concepts.\n\n- Linux and Windows.\n\n- ISTQB certification.\n\n- Experience working with regulated product development environments.\n\nEducation:\n\n- Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Information Technology, or Electronics/related engineering discipline.\n\nKey Competencies:\n\n- Strong analytical and problem-solving skills.\n\n- Excellent attention to detail.\n\n- Strong quality and compliance mindset.\n\n- Good communication and collaboration skills.\n\n- Ability to work independently in cross-functional teams.\n\n- Strong automation and continuous-improvement mindset.\n\n- Sound knowledge of SDLC and Software V&V.\nSkills\nSoftware Quality Assurance, Automation Testing, Testing, C#, .Net, TypeScript, 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