Device Development Engineer (m/f)

- Support the EU Biologics Device Development Team
- Integration of container closure with delivery systems
- Risk assessment, mitigation and management
- Manage and deliver Device Development aspects of Combination

Product technical development projects under Design Control philosophy - Working in compliance with the Quality System
- Responsibility for the adequacy and Good Document Practice of all technical documentation according to 21CFR820, 93/42/EEC and internal procedures
- Technical contribution to internal Quality Audits, Supplier Audits, Pre-Approval and Routine Health Authority/Notified Body Inspections
- Be a technical support
- University level education, preferably with an engineering degree
- Strong experience in track record, in medical device, special/innovative packaging, or development sector specializing in compact, complex, multi-material hand-held products
- Experience of working in pharma or other closely-regulated environment, under cGxP, QSR
- Project management and/or leadership experience
- Sound knowledge of legislation, regulation, industry standards and guidance
- Excellent command of English, with German an advantage
- Travel is required between 20%
- Excellent IT knowledge
- Excellent collaborative and oral/interpersonal/communication skills

Weitere Qualifikationen: Business development manager