Lead Digital Health Quality Engineer

Role: Lead Digital Health Quality Engineer specializing in SaMD and Digital Health software development, ensuring compliance with regulatory standards throughout the product lifecycle. Responsibilities include managing design controls, risk management (including cybersecurity per ISO 14971), software validation (CSA, GAMP5), document review and approval, supporting regulatory submissions, and leading quality process improvements. The role involves cross-functional collaboration with technical teams and supporting audits and CAPA activities. Qualifications: Bachelor's degree with 6+ years, or advanced degree with fewer years, in a relevant field; experience in quality systems and medical device regulation (IEC 62304, ISO 14971, 21 CFR 820.30, EU MDR); strong technical writing, analytical, and communication skills. Preferred: familiarity with medical device cybersecurity, AI/ML, Connected Devices, and emerging Digital Health technologies. High-value: focus on SaMD/Digital Health, cybersecurity risk management, software validation, regulatory compliance, and cross-functional leadership in a regulated environment. Work setup: not specified, but implies a collaborative, compliance-driven role.