Iso 14971 Jobs

Experienced Validation Engineer III needed to lead complex design verification and validation efforts for medical device software systems, ensuring regulatory compliance and driving process innovation.

Foresight Diagnostics seeks a Senior Specialist, Regulatory Affairs to lead US regulatory strategy and submissions for next-generation sequencing-based IVD products while partnering cross-functionally through development and lifecycle management.

Gilead is hiring an Associate Director of Device Engineering to lead and develop engineering teams delivering parenteral drug-device combination products while ensuring regulatory and design-control compliance.

Plexus is hiring a Design Assurance Engineer intern in Neenah, WI to assist with medical device compliance, verification testing, and risk management activities for new product development.

Lead regulatory strategy and submissions for PROCEPT BioRobotics' surgical robotics products, guiding projects from development through market approval and post-market activities.

Artera is hiring a Systems Engineer to lead requirements, risk management, system architecture, and usability engineering for its AI medical-device products.

Lead systems-level solutions and sustaining engineering at Insulet as a Principal Systems Engineer, providing technical leadership across design, post-market support, and regulatory-compliant lifecycle activities.

Lead requirements engineering and traceability for Insulet's next-gen wearable medical device software, ensuring compliance and clear, testable requirements across mobile and cloud systems.

Experienced systems engineering leader needed to drive sustaining engineering, root-cause resolution, and regulatory-compliant product improvements for Insulet's wearable drug-delivery platform in a hybrid Massachusetts role.

Senior quality executive needed to lead Irvine and global laboratory operations, standardize best-in-class systems, and ensure regulatory compliance across the organization.