Sr. Principal Engineer, PDO & Verification

Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization; Create and maintain product and software architecture, user interface design, and specifications that meet customer needs and regulatory requirements; Utilize systems engineering and design thinking to define functional and performance requirements for products and systems; Model behaviors across systems and conduct risk analysis from a systems perspective; Perform risk management activities, including analysis, evaluation, and mitigation, in accordance with ISO 14971; Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards; Conduct integration and system validation testing for Kubernetes-based digital platforms in On-Prem and Cloud environments; Prepare technical documentation (design plans, traceability matrices, test reports) in compliance with FDA-approved quality processes for Class I/II and MDDS products; Train and mentor the systems team.