Senior Design Software Quality Engineer

Senior Design Software Quality Engineer (Medical Devices) — Multi-Portfolio StartupLocation: US-based, Wilmington, MA (hybrid will be considered)Function: Quality Reports to: Head of Quality ManagementPosition SummaryHands-on Sr. Design Quality Engineer serving as the primary QA owner for assigned projects, driving design quality activities across the product lifecycle from concept through commercialization. Responsible for ensuring compliance with design controls, risk management, verification and validation, and applicable regulatory requirements, while maintaining strong ownership and alignment with QA management.Core ResponsibilitiesThe responsibilities listed below are representative of the position and are not intended to be an exhaustive list of all duties that may be assigned.Execute quality assurance activities throughout product design and development in accordance with applicable regulations, standards, and company procedures.Support the development, maintenance, and review of design control deliverables.Support implementation and maintenance of the electronic Quality Management System (eQMS), including management of design inputs, risk management documentation, and other quality and product records.Author, review, and drive verification and validation activities, including protocols, reports, and closure documentation.Author and/or support test method validation activities, including Gauge R&R studies, Attribute Agreement Analysis, and software tool validation.Author, review, and drive risk management activities, including Risk Management Plans, Hazard Analyses, FMEAs, and Risk Management Reports.Collaborate with cross-functional teams to ensure design control activities are executed in accordance with company procedures and applicable regulatory requirements.Support Quality Management System (QMS) compliance, continuous improvement initiatives, and audit readiness activities.Support compliance activities related to medical device software lifecycle processes (IEC 62304) and usability engineering (IEC 62366-1).Work effectively within small, cross-functional teams while managing multiple priorities and assignments.Travel up to 10% as required.Education, Experience and Background RequirementsBachelor's degree in Engineering, Life Sciences, or a related technical field.7+ years of experience in Quality Engineering, Design Quality Engineering, or product development quality roles within the medical device industry.Hands-on experience applying IEC 62304 requirements and relevant FDA guidance to the design and development of medical devices containing softwareStrong experience supporting design controls, risk management, and verification & validation activities.Experience working in a startup or fast-paced product development environment preferred.Analog Devices is an equal opportunity employer.

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