Senior Design Quality Engineer

Required

• A quality engineering subject matter expert who can guide cross-functional teams through complex, regulated product development and commercialization activities.
• A risk-based decision maker who protects patient safety and product quality while thoughtfully balancing schedule, cost, technical, and business constraints.
• An owner who solves complex problems with minimal oversight, follows issues through to resolution, and escalates risks that could affect safety, compliance, or launch readiness.
• A clear communicator who can translate complex technical, quality, and regulatory information for engineers, cross-functional partners, and executive stakeholders.
• A collaborative coach who makes design quality practical and relevant, helping teams adopt strong practices without relying solely on authority or procedure.
• A Learn-it-all who stays curious about evolving medical-device standards, software-enabled products, reliability methods, and better ways to scale quality.
• Bachelor’s degree in electrical engineering, mechanical engineering, systems engineering, mathematics, physics, or a related technical field.
• 6+ years of experience in quality engineering or a related field, including at least 4 years in a medical-device design and development environment.
• 3+ years of experience applying design controls and risk management from early design and development through commercialization, including experience with electromechanical systems and applicable medical-device standards such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820.