Description
We are recruiting for Technical Expert in Combination Devices, where you will be leading project teams in the development of parenteral delivery systems, e.g. drug/device combination products with main focus on devices for parenteral administration.Responsibilities:
- Participate in packaging development activities whilst maintaining a solid knowledge on materials (glass, polymers, rubbers, silicone/lubricants, sterile barrier systems, adhesives) and 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
- Lead the collaboration with external development partners;
- Monitor work progress according to plan;
- Monitor, support and challenge technical development as well as test and verification work
- Monitor development and implementation of manufacturing processes;
Requirements:
- Experience in leading packaging/device/combination product projects;
- Experience in Project Management Office
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
- Experience in Product design and Design for manufacture;
- Experience of managing external suppliers;
- Good communication and conflict solving skills;
- Good technical knowledge of primary containers development;
- General understanding of Human Factors Engineering and Risk management ;
- Good understanding of clinic studies processes and requirements;
- Good understanding of pharmaceutical development in general;
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.