Staff Design Quality Engineer

Key ResponsibilitiesManage product and supplier-related change activities, including supplier change requests, component obsolescence, product updates, reliability improvements, and lifecycle management initiatives.Support risk-based decision-making related to product safety, compliance, field risk, stop-ship situations, and other business-critical quality or manufacturing concerns.Partner cross-functionally with engineering, quality, regulatory, manufacturing, supplier quality, and operations teams to evaluate product impact and determine the appropriate level of action.Apply design quality principles to product changes, lifecycle management projects, reliability improvements, and regulated product decision-making.Assess technical issues, right-size solutions, and ensure project actions are appropriate to the scope, risk, and compliance impact of the issue.Provide mentorship and technical guidance to less experienced engineers.Identify gaps across product, quality, and lifecycle management processes and help drive improvements where needed.Support quality system updates where they connect directly to product, design quality, lifecycle management, and risk mitigation.Communicate effectively with engineering and cross-functional stakeholders, including the ability to challenge assumptions and influence decisions in a practical, professional manner.Ideal BackgroundBachelor's degree in Electrical Engineering preferred; Mechanical Engineering, Systems Engineering, Biomedical Engineering, or related technical disciplines may also be considered.Approximately 5–7+ years of relevant engineering experience in the medical device or similarly regulated industry.Experience in product development, design engineering, design quality, lifecycle management, reliability engineering, or product-focused quality engineering.Prior experience supporting Class I, II, and/or III medical devices.Strong understanding of how design, quality, regulatory, manufacturing, supplier changes, and product risk connect across the product lifecycle.Practical experience managing or supporting supplier changes, product changes, component obsolescence, reliability improvements, or lifecycle management projects.Ability to provide specific examples of projects personally owned or directly supported.Experience making risk-based decisions where safety, compliance, technical complexity, and business needs must all be balanced.Technical & Regulatory KnowledgeWorking knowledge of applicable medical device standards and regulations, including some or all of the following:ISO 14971 — Risk Management for Medical DevicesISO 13485 — Medical Device Quality Management SystemsISO 10993 — Biological Evaluation / BiocompatibilityIEC 62366 — Usability Engineering / Human FactorsIEC 60601 — Electrical Safety and Essential PerformanceIEC 62304 — Medical Device Software Lifecycle Processes