Adsano Engineering offers a wide range of services in the pharmaceutical sector. From executive selection, recruitment consultancy to staffing, Adsano is dedicated to providing the best suited personnel for the Life Science Industry.

Our client, a global player in the pharmaceutical technology field, based in Basel Switzerland, has an opening for:
Medical Device Project Leader (m/w/d) 30123
Job Purpose 

The successful candidate for this position will need to be able to lead the technical development of packaging and/or drug delivery systems within the Packaging & Device Development Team, from early phase activities up to commercialization and production scale up. In addition to outstanding project management and inter-personal skills, a strong technical background in medical devices and in pharmaceutical packaging development is crucial to support, monitor and challenge internal and external development partners. 


Major accountabilities
  • Thorough project planning
  • Leading the definition of product requirements for packaging, medical devices, delivery systems, e.g. drug/device combination products in which the device is generally already registered but sometimes to be developed 
  • Leading 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 
  • Managing the collaboration with internal development partners and stakeholders 
  • Provide primary packaging and device expertise in a broader cross-functional drug product development team
  • Evaluating and challenging technical solutions 
  • Supporting and coordinating the manufacturing of clinical material and the production scale up 
  • Supporting cross functional project teams in the development, review and submission of regulatory dossiers 
  • Managing and monitoring Human Factors Engineering activities 
  • Leading Risk management activities
  • Planning and monitoring of design verification activities (in-house)
  • Leading and authoring technical documentation
  • Ensuring a high quality Design History file
  • Transfer of Design History File to production 

Education / Experience
  • University degree in science, engineering or equivalent
  • min. 5 years of practical experience in leading device development technical teams in a similar area 
  • Fluency in English language is required. Proficiency in German/French advantageous. 
  • Good understanding of pharmaceutical development in general 
  • Experience in project / program management of complex projects 
  • Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)
  • Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
  • Test and verification, incl. development of methods and equipment 
  • General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements
  • Good communication and conflict solving skills

Workload: 100%
Duration: 1 year
Location: Basel



Any questions? Feel free to contact Annette Deutschbein at + 49 176 313 954 29 or send your CV to: career@adsano.com



 
Adsano Engineering AG



career@adsano.com
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