Boston Scientific is seeking an Engineer II to support Product Assurance through Verification and Validation of medical devices, ensuring compliance with regulatory standards and delivering safe, effective, and innovative technologies that improve patient outcomes.
Requirements
- supporting the development of test strategies, applying relevant statistical techniques, and executing structured testing procedures.
- Design, develop, and execute test cases and test methods to verify system functionality and ensure business and user requirements are met; document results and author detailed test reports.
- Develop and maintain software development lifecycle (SDLC) documentation, traceability matrices, and design records to support regulatory submissions and internal quality management systems.
- Establish, implement, and maintain quality systems in accordance with FDA regulations, ISO 13485, IEC 62304, and other applicable international standards.
- Assist in internal and external audits to evaluate GMP and ISO compliance, support the identification of risks—including cybersecurity vulnerabilities, and contribute to recommending corrective actions that uphold product integrity and regulatory readiness.
- Possess strong knowledge of comprehensive risk management documentation, including Hazard Analysis, Task Analysis, and Design FMEAs, with familiarity in applying advanced risk mitigation strategies.
- Participate in design verification, validation, and usability testing activities, contributing to alignment with internal and external requirements.
Responsibilities
- Contribute to software verification and validation by supporting the development of test strategies, applying relevant statistical techniques, and executing structured testing procedures.
- Design, develop, and execute test cases and test methods to verify system functionality and ensure business and user requirements are met; document results and author detailed test reports.
- Develop and maintain software development lifecycle (SDLC) documentation, traceability matrices, and design records to support regulatory submissions and internal quality management systems.
- Establish, implement, and maintain quality systems in accordance with FDA regulations, ISO 13485, IEC 62304, and other applicable international standards.
- Assist in internal and external audits to evaluate GMP and ISO compliance, support the identification of risks—including cybersecurity vulnerabilities, and contribute to recommending corrective actions that uphold product integrity and regulatory readiness.
- Collaborate closely with software development, hardware engineering, and other cross-functional teams; actively participate in scrum meetings, product reviews, and bug triage sessions.
- Participate in design verification, validation, and usability testing activities, contributing to alignment with internal and external requirements.
Other
- Represent the Product Assurance function within cross-functional product teams, ensuring quality assurance, usability, and regulatory compliance throughout the product lifecycle.
- Collaborate closely with software development, hardware engineering, and other cross-functional teams; actively participate in scrum meetings, product reviews, and bug triage sessions.
- Support junior engineers by sharing technical insights related to product assurance, regulatory compliance, and software quality practices.
- Contribute to continuous improvement efforts by helping identify process gaps, refine tools and documentation, and promote quality-focused practices.
- Minimum of 2 years of experience in a Quality Assurance role, preferably within a regulated industry
