{"id":2794072,"url":"https://alion.io/job/boston-scientific-engineer-ii-software-quality-assurance","title":"Engineer II, Software Quality Assurance","company":{"id":1758528,"name":"Boston Scientific","domain":"bostonscientific.com","url":"https://alion.io/company/bostonscientific-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Eightfold","truth_index":{"grade":"B","score":80,"open_postings":71,"ghost_share":0.014,"stale_share":0.746,"repost_share":0.028,"time_to_fill_p50_days":29,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Gurgaon, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Verification & Validation","optional":false},{"name":"Agile","optional":true},{"name":"Jira","optional":true}],"status":"live","first_seen_at":"2026-10-08T10:03:12Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-10-21T14:50:44Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"Additional Locations: N/A\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\nAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.\nSoftware Quality Assurance Engineer II\nAbout the role\nThe Software Quality Assurance (SWQA) Engineer II provides quality and compliance support for medical device software development programs. This role partners with cross-functional teams to ensure software products are developed, verified, validated, and maintained in accordance with company procedures, regulatory requirements, and industry standards. Responsibilities include software design controls, risk management, verification and validation reviews, change assessments, and quality oversight throughout the product lifecycle.\nKey Responsibilities:\nProvide Quality Assurance support for software development and sustaining engineering projects.\nReview software lifecycle deliverables including requirements, design documentation, traceability artifacts, verification and validation protocols/reports, and release documentation.\nParticipate in software risk management activities, including hazard analysis, risk assessments, and verification of risk controls.\nReview software verification and validation activities to ensure appropriate coverage, traceability, and objective evidence.\nSupport Software Change Assessments (SCA), impact assessments, CAPA, remediation, and post-market quality activities.\nPartner with R&D, Systems Engineering, Regulatory Affairs, and Program teams to ensure compliance with software design control requirements.\nSupport compliance with applicable standards and regulations, including IEC 62304, ISO 13485, ISO 14971, and FDA QSR.\nParticipate in continuous improvement initiatives and support audit readiness activities.\nRequired Qualifications:\nBachelor's degree in Computer Science Engineering, Software Engineering, or equivalent.\n3+ years of experience in Software Quality, Software Development, Software Verification & Validation, or related engineering function.\nKnowledge of Software Development Lifecycle (SDLC) processes.\nStrong analytical, problem-solving, and communication skills.\nAbility to work effectively in a cross-functional environment.\nPreferred Qualifications:\nExperience in a regulated industry such as Medical Devices, Healthcare, Aerospace, or Automotive.\nKnowledge of IEC 62304, ISO 13485, ISO 14971, and FDA Design Controls.\nExperience with software design controls, risk management, and software validation.\nFamiliarity with Agile development methodologies and lifecycle management tools such as Windchill, Jira.\nExposure to cybersecurity, CAPA, remediation, or post-market quality activities.\nRequisition ID: 635987\nBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. 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