For our Swiss customer located in Basel we are currently looking for (m/f) a Medical Device Technical Expert
- Type of placement: 5 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
Lead and manage technical activities and apply expertise to address complex design, development and operational issues for the design development of primary packaging for combination products, processes and procedures.
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.
Develop and optimize manufacturing processes for combination products.
Primary Packaging Technology Activities
- Coordinate primary packaging development activities with the project team members for assigned projects
- Maintain knowledge in the areas of materials (glass, polymer, pharmaceutical rubber, silicone/ lubricants, sterile barrier systems, adhesives). Manufacturing (injection moulding, glass converting, rubber moulding, assembly, fill & finish, transport validation)
- Develop primary packaging concepts to support early phase development
- Conduct feasibility assessments on new technology/ packaging concepts
- Develop early and late phase primary 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
- Education (minimum/desirable): Minimum: BS/MS or equivalent
- Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).
- Languages: Good knowledge of English (oral and written). Desirable knowledge of site language.
- Successfully demonstrated min. 3 years of directly related experience in primary packaging design development
- Recognized expertise in a specific area i.e. material, design development, primary packaging production processes, biomolecule primary packaging, ophthalmology devices
- Thorough knowledge of state-of-art technology/equipment/regulation as appropriate for the role.
- Thorough understanding of packaging and medical devices development processes
- Ability to work in and/or lead interdisciplinary and/or cross-cultural teams
- Proven leadership skills
- Strong communication skills, strong presentation skills and scientific/technical writing skills, advanced coaching skills