Staff Software Quality Engineer, Design Assurance - Stryker Corporation : Job Details

Execute quality assurance activities for new product development within Stryker's global Digital Health Portfolio, focusing on Acute Care in the Medical Division. Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance requirements. Partner with cross-functional teams, including marketing, R&D, clinical, regulatory, and operations, to deliver quality, compliant products. Oversee risk management using ISO 14971standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership. Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA, TGA, EUMDR, IT). Engage in design and development activities for both medical and non-medical software, including Sa. MD, MDDS, and AI/ ML solutions. Implement standard development practices, ...Quality Engineer, Software, Staff, Engineer, Design, Quality, Manufacturing, Technology