SW Quality Assurance Engineer I

Boston Scientific is a leader in medical science dedicated to advancing science for life. The Software Quality Assurance Engineer I will provide critical Quality Engineering input across Neuromodulation Software and Firmware product development, ensuring compliance and quality throughout the product lifecycle.ResponsibilitiesWork collaboratively within a team of Product Software Quality Assurance EngineersContribute to all aspects of Software and Firmware Quality Assurance in a highly regulated active implantable and capital equipment medical device environmentEnsure the quality of software systems by validating software and firmware requirements, security requirements, and compliance with applicable standardsSupport design, development, and test of software related to all Boston Scientific Neuromodulation product lines throughout the full development life cycleSupport the creation and execution of Design Validation Plans, protocols, and reports, including system‑level testing, and document and escalate any issues identifiedReview software and firmware design, development, and testing activities to ensure adherence to quality and regulatory expectationsReview and approve documentation including user requirements, hazard analysis, security risk assessments, usability, functional and design specifications, design reviews, test protocols, and requirements traceabilitySupport Automated Test Equipment (ATE) validation activitiesSupport software‑related CAPA (Corrective and Preventive Actions) activitiesSupport Design Validation activities, including review of User Needs Requirements, Design Requirements, Functional and Architectural design, module-level design, code reviews, unit and integration testing, system-level testing (black box), structural testing (white box), test automation, ad hoc/exploratory testing, cybersecurity, usability, and risk management (including Design FMEAs and Hazard Analysis)SkillsMinimum of a BS degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or other related engineering disciplineMinimum of 1 year's experienceWorking knowledge of testing processes and methodologiesManual system-level testing experience in a regulated environmentSome knowledge of mobile application developmentSome experience in programming languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, or LabViewMS degree in Computer Science, Software Engineering, or Electrical EngineeringExcellent organizational, verbal, and written communication skillsTeam-oriented with strong interpersonal skills and a positive, can-do attitude when managing competing priorities across departmentsDetail-oriented with a passion for building quality into productsExperience working in the medical device industry or other highly regulated environmentsBasic academic knowledge of principles of NeuromodulationSome experience with CAPA, complaint handling, and external auditsUnderstanding of Risk Management per ISO 14971Familiarity with Premarket and Postmarket Cybersecurity Guidance and IEC 81001-5-1Understanding of Bluetooth technologyAwareness of HIPAA and GDPR compliance practicesASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) certificationCompany OverviewBoston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition. It was founded in 1979, and is headquartered in Marlborough, Massachusetts, USA, with a workforce of 10001+ employees. Its website is http://www.bostonscientific.com.



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