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.
Responsibilities
- Work collaboratively within a team of Product Software Quality Assurance Engineers
- Contribute to all aspects of Software and Firmware Quality Assurance in a highly regulated active implantable and capital equipment medical device environment
- Ensure the quality of software systems by validating software and firmware requirements, security requirements, and compliance with applicable standards
- Support design, development, and test of software related to all Boston Scientific Neuromodulation product lines throughout the full development life cycle
- Support the creation and execution of Design Validation Plans, protocols, and reports, including system‑level testing, and document and escalate any issues identified
- Review software and firmware design, development, and testing activities to ensure adherence to quality and regulatory expectations
- Review and approve documentation including user requirements, hazard analysis, security risk assessments, usability, functional and design specifications, design reviews, test protocols, and requirements traceability
- Support Automated Test Equipment (ATE) validation activities
- Support software‑related CAPA (Corrective and Preventive Actions) activities
- Support 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)
Skills
- Minimum of a BS degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or other related engineering discipline
- Minimum of 1 year's experience
- Working knowledge of testing processes and methodologies
- Manual system-level testing experience in a regulated environment
- Some knowledge of mobile application development
- Some experience in programming languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, or LabView
- MS degree in Computer Science, Software Engineering, or Electrical Engineering
- Excellent organizational, verbal, and written communication skills
- Team-oriented with strong interpersonal skills and a positive, can-do attitude when managing competing priorities across departments
- Detail-oriented with a passion for building quality into products
- Experience working in the medical device industry or other highly regulated environments
- Basic academic knowledge of principles of Neuromodulation
- Some experience with CAPA, complaint handling, and external audits
- Understanding of Risk Management per ISO 14971
- Familiarity with Premarket and Postmarket Cybersecurity Guidance and IEC 81001-5-1
- Understanding of Bluetooth technology
- Awareness of HIPAA and GDPR compliance practices
- ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) certification
Company Overview
Boston 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.