American Free Zone, San Franci Senior Design Quality Engineer AFZ

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. About the role: We are seeking a highly motivated and experienced Senior Quality Engineer to support sustaining engineering activities for commercialized medical devices throughout their lifecycle. In this role, you will help maintain and improve product safety, quality, reliability, and performance by providing quality engineering expertise for design changes, product investigations, corrective and preventive actions (CAPAs), and post-market quality activities. You will collaborate with R&D, Manufacturing, Regulatory Affairs, Post-Market Quality, and other stakeholders to assess product-related issues, evaluate design impacts, identify improvement opportunities, and support compliance with applicable regulatory requirements and quality standards. The ideal candidate brings strong technical judgment, analytical problem-solving capabilities, a risk-based mindset, and the ability to independently manage complex quality engineering activities while influencing technical decisions. Work Mode: This role follows a hybrid work model. Employees are expected to work from the Global Hub, American Free Zone, Costa Rica office at least three days per week, with the remaining days worked remotely. Your responsibilities will include: Provide Design Quality Engineering support for sustaining activities associated with commercialized medical devices, including design changes, product improvements, quality investigations, and cross-functional projects. Lead and support quality assessments of design changes, evaluating potential impacts on product safety, performance, risk management, and regulatory compliance. Apply design controls to sustaining activities, including design requirements, risk management, verification, validation, and design history documentation, as applicable. Lead and support nonconforming event processes (NCEPs), product impact assessments, and CAPA activities related to product design, performance, and quality improvements. Evaluate post-market quality information, including product complaints, field performance data, and emerging quality trends, to identify design-related issues and improvement opportunities. Support product risk management activities, including assessment of new hazards, updates to risk analyses, evaluation of risk controls, and residual risk assessments in accordance with ISO 14971. Partner with R&D and cross-functional teams to define verification and validation strategies for design changes and provide quality expertise during product investigations, failure analysis, and structured problem-solving activities. Review and approve technical documentation and quality records for compliance with applicable procedures, regulatory requirements, and quality system expectations. Participate in cross-functional sustaining engineering and improvement initiatives involving R&D, Manufacturing, Quality, and Regulatory Affairs. Provide technical guidance and mentorship to engineers and cross-functional teams on design quality principles, product risk management, and structured problem-solving methodologies. Required qualifications: Bachelor's degree in Engineering or a related technical discipline. 5+ years of relevant experience in medical device quality engineering, design quality, sustaining engineering, product engineering, or a related field. Experience supporting commercialized medical devices, including sustaining design changes, product improvements, product investigations, or quality improvement activities. Working knowledge of medical device design controls, risk management principles, and applicable quality system requirements, including ISO 13485, ISO 14971, and FDA regulations. Experience leading or supporting nonconformance investigations, root cause analysis, NCEPs, and CAPA processes involving product or design-related issues. Ability to assess technical changes and product-related issues for potential impacts on product safety, performance, and quality, and to review related technical documentation. Strong analytical problem-solving, decision-making, written and verbal communication skills , with demonstrated ability to work independently, manage competing priorities, and collaborate across functions. Preferred qualifications: Master's degree in Engineering or a related technical discipline. Experience with active implantable medical devices, neuromodulation systems, or other complex medical technologies. Experience analyzing post-market quality data, complaint trends, and product performance to support risk-based decisions. Advanced knowledge of ISO 14971, ISO 13485, and applicable medical device regulatory requirements. Requisition ID: 636775 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 . 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