Principal Design Quality Engineer

You will serve as the design quality engineering lead across product development teams, overseeing all aspects of design control, risk management, and software verification & validation. Occasional travel is required for on-site team meetings and cross-functional projects.AccountabilitiesLead design quality engineering activities for software medical device projects, ensuring compliance with applicable regulatory standards and internal Quality Management System (QMS).Review and approve design documentation including user needs, requirements specifications, architecture, and verification & validation plans and reports.Facilitate and maintain risk management activities throughout the product lifecycle in alignment with ISO 14971.Provide oversight of software development lifecycle (SDLC) processes, ensuring quality is integrated into agile workflows.Participate in design reviews, technical meetings, and software issue triage to assess risks and drive prioritization.Maintain accurate Design History Files (DHF) and ensure readiness for audits and regulatory inspections.Lead training initiatives to strengthen quality practices across teams and support corrective and preventive actions (CAPA) as needed.RequirementsBachelor’s degree in engineering, computer science, or related discipline.12+ years of experience in Design Quality or Quality Engineering within the medical device industry, with a focus on software as a medical device (SaMD).In-depth knowledge and practical experience with ISO 13485, IEC 62304, ISO 14971,...