Engineer II, Software Quality Assurance
Boston Scientific (company site, opens in a new tab)3+ yrsGurugramOn-siteDirect career pageEst. 8–16 LPA
Posted 1d ago
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Job description
Structured overview of role & requirements
About This Role
- Own Quality Assurance support for medical device software development and sustaining engineering projects, ensuring compliance with company procedures and regulatory requirements.
- Review and oversee software lifecycle deliverables including requirements, design documents, verification and validation protocols/reports, and release documentation for quality and traceability.
- Lead software risk management activities and support change assessments, CAPA, remediation, post-market quality activities, and audit readiness processes.
Minimum Requirements
- Bachelor's degree in Computer Science Engineering, Software Engineering, or equivalent.
- 3+ years of experience in Software Quality, Software Development, Software Verification & Validation, or related engineering function.
- Knowledge of Software Development Lifecycle (SDLC) processes.
- Familiarity with regulatory standards such as IEC 62304, ISO 13485, ISO 14971, and FDA QSR is required.
Ideal Candidate Profile
- Experienced in regulated industries (Medical Devices, Healthcare, Aerospace, or Automotive) with solid understanding of software design controls, risk management, and software validation.
- Comfortable working cross-functionally with R&D, Systems Engineering, Regulatory Affairs, and Program teams ensuring compliance and product quality.
- Familiar with Agile development methodologies and lifecycle management tools like Windchill or Jira; exposure to cybersecurity, CAPA, remediation, or post-market quality activities is advantageous.