Medical Device Technical Expert / no-851

Status: 
paused
Location: 
4070 Basel
Start Date: 
2018-05-30
End Date: 
2018-10-31
Hours per day: 
8,00
Hours per week: 
36,00
Workload: 
100%
Total Hours: 
956
Assignment: 

Background

 

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

 

Job Purpose: 

 

  • 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 
Requirements: 

Ideal Background

  • 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. 

Experience/Professional requirement

  • 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