The role
04Your responsibilities include, but are not limited to:
01Provide technical leadership in cross-functional device development subteams for autoinjector and other drug-device combination product development projects
02Define design input requirements and specifications, and author, review, and approve Design History File (DHF) documentation
03Lead design verification and characterization activities to demonstrate compliance with applicable requirements, standards, and intended use
04Provide technical input to regulatory submission dossiers and support responses to health authority questions related to device design, performance, and verification activities.
05Perform technical investigations and root cause analyses, identify corrective actions, and implement robust technical solutions to prevent recurrence of product and process issues.
06Ensure development activities comply with applicable regulations, standards, and internal procedures
07Collaborate with external partners, suppliers, contract manufacturers, and internal manufacturing organizations to ensure successful device development and industrialization.
08Ensure documentation and materials are delivered to support clinical studies, registration, and commercial manufacturing.
09Provide scientific and technical guidance to team members, facilitate knowledge sharing, and contribute to the development of engineering best practices.
