You will lead and manage technical activities and apply expertise to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products, processes and procedures. You will compile Design Control documentation and contributing to a high quality Design History File (DHF). Author and Review of DHF relevant documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects. You will consult on the development and/or optimization manufacturing processes for medical devices and combination products.
* Coordinate packaging development activities with the project team members for assigned projects
* Maintain knowledge in the areas of materials (glass, polymers, rubbers, silicone/lubricants, sterile barrier systems, adhesives). Manufacturing (injection moulding, glass converting, rubber moulding, assembly, fill & finish, transport validation)
* Develop packaging concepts to support early phase development
* Conduct feasibility assessments on new technology/ packaging concepts
* Develop early and late phase packaging prototypes using rapid prototyping, machined and/or soft tooling
* Conduct design for manufacture assessments
* Conduct tolerance stack analyses
* Maintain technical drawings and models
* Contribute to risk analyses
* Develop Design Input Requirements
Michael Bailey International is acting as an Employment Business in relation to this vacancy.