Job description

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At 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. Software Quality Assurance Engineer II About the role The 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. Key Responsibilities: • Provide Quality Assurance support for software development and sustaining engineering projects. • Review software lifecycle deliverables including requirements, design documentation, traceability artifacts, verification and validation protocols/reports, and release documentation. • Participate in software risk management activities, including hazard analysis, risk assessments, and verification of risk controls. • Review software verification and validation activities to ensure appropriate coverage, traceability, and objective evidence. • Support Software Change Assessments (SCA), impact assessments, CAPA, remediation, and post-market quality activities. • Partner with R&D, Systems Engineering, Regulatory Affairs, and Program teams to ensure compliance with software design control requirements. • Support compliance with applicable standards and regulations, including IEC 62304, ISO 13485, ISO 14971, and FDA QSR. • Participate in continuous improvement initiatives and support audit readiness activities. Required Qualifications: • 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. • Strong analytical, problem-solving, and communication skills. • Ability to work effectively in a cross-functional environment. Preferred Qualifications: • Experience in a regulated industry such as Medical Devices, Healthcare, Aerospace, or Automotive. • Knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA Design Controls. • Experience with software design controls, risk management, and software validation. • Familiarity with Agile development methodologies and lifecycle management tools such as Windchill, Jira. • Exposure to cybersecurity, CAPA, remediation, or post-market quality activities. Requisition ID: 635987 Boston 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. Learn more at  www.bostonscientific.com  and follow us on  LinkedIn .

Requirements

Must-haves

Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
Software Quality Assurance Engineer II
Provide Quality Assurance support for software development and sustaining engineering projects.
Review software lifecycle deliverables including requirements, design documentation, traceability artifacts, verification and validation protocols/reports, and release documentation.
Participate in software risk management activities, including hazard analysis, risk assessments, and verification of risk controls.
Review software verification and validation activities to ensure appropriate coverage, traceability, and objective evidence.
Support Software Change Assessments (SCA), impact assessments, CAPA, remediation, and post-market quality activities.
Partner with R&D, Systems Engineering, Regulatory Affairs, and Program teams to ensure compliance with software design control requirements.
Support compliance with applicable standards and regulations, including IEC 62304, ISO 13485, ISO 14971, and FDA QSR.
Participate in continuous improvement initiatives and support audit readiness activities.
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.
Strong analytical, problem-solving, and communication skills.
Ability to work effectively in a cross-functional environment.

Nice-to-haves

Experience in a regulated industry such as Medical Devices, Healthcare, Aerospace, or Automotive.
Knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA Design Controls.
Experience with software design controls, risk management, and software validation.
Familiarity with Agile development methodologies and lifecycle management tools such as Windchill, Jira.
Exposure to cybersecurity, CAPA, remediation, or post-market quality activities.
Requisition ID: 635987

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agilejira

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Effort: medium