Device Development Engineer (m/f)

- Need to work within the Device Development Team and focus on the development of combination products
- Manage device development aspects of combination product technical development projects
- Working in compliance with the company's quality system
- Responsibility for the adequacy and Good Document Practice of all technical documentation according to 21CFR820 & 93/42/EEC
- Technical contribution to internal quality audits, supplier audits, pre-approval and routine health authority
- Responsible for pre-fillable container closures (primarily syringes: Luer-slip, Luer-lock cone and staked needle)
- Contribute to external working groups, industry forums, ISO committees

- Profound track record and experience in the area of medical devices, special/innovative packaging
- Project management and/or leadership experience
- Sound knowledge of legislation, regulation & industry standards
- Demonstrable knowledge of primary container closure materials (eg. glass, elastomers, adhesives), treatments, surface coatings, manufacturing processes
- Parenteral drug delivery (eg: subcutaneous, intravenous, intramuscular, transdermal)
- Design for manufacture
- Risk assessment
- Transport studies and validation
- Excellent command of English

Weitere Qualifikationen: Project manager