Boston Scientific
Product Assurance Engineer II
Work mode: Onsite Onsite Location(s): Irvine, CA, US, 92602 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. About the Role
We are seeking a skilled, highly motivated and detail-oriented Engineer II to support Product Assurance through Verification and Validation of medical devices, ensuring compliance with IEC 62304, FDA, ISO 13485, ISO 14971 and other regulatory standards governing medical devices. The ideal candidate will bring strong engineering expertise, hands-on testing experience, and a solid understanding of regulatory and quality systems. This role is vital to delivering safe, effective, and innovative technologies that improve patient outcomes. At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office 5 days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your Responsibilities Will Include:
Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on multiple and moderately complex processes. Represent the Product Assurance function within cross-functional product development teams, ensuring quality assurance, usability, and regulatory compliance throughout the product lifecycle. 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 risksincluding 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. 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. 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. Required Qualifications
Bachelor's degree in Engineering, Science, or a related technical field At least 2 years of experience in a Quality Assurance role, preferably within a regulated industry Preferred Qualifications
Medical device industry experience
Work mode: Onsite Onsite Location(s): Irvine, CA, US, 92602 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. About the Role
We are seeking a skilled, highly motivated and detail-oriented Engineer II to support Product Assurance through Verification and Validation of medical devices, ensuring compliance with IEC 62304, FDA, ISO 13485, ISO 14971 and other regulatory standards governing medical devices. The ideal candidate will bring strong engineering expertise, hands-on testing experience, and a solid understanding of regulatory and quality systems. This role is vital to delivering safe, effective, and innovative technologies that improve patient outcomes. At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office 5 days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your Responsibilities Will Include:
Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on multiple and moderately complex processes. Represent the Product Assurance function within cross-functional product development teams, ensuring quality assurance, usability, and regulatory compliance throughout the product lifecycle. 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 risksincluding 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. 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. 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. Required Qualifications
Bachelor's degree in Engineering, Science, or a related technical field At least 2 years of experience in a Quality Assurance role, preferably within a regulated industry Preferred Qualifications
Medical device industry experience