Beschreibung
Medical Device Project Leader wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- 7+ years' work experience in leading device development
- Domain knowledge in pharmaceutical development along with expertise as a project or program manager of complex projects
- Strong understanding of medical device regulations such as FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive and EU Medical Device Regulation
- Competency in development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory as well as QA and GMP aspects
- Relevant work experience as a Mechanical Engineer, Product Designer for manufacture, test and verification in combination with development of methods and equipment
- Familiarity with Human Factors Engineering, Risk Management as well as clinical studies processes and requirements
- University degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education
- Languages: fluent English both written and spoken, German or French is a plus
Your tasks:
- Providing the definition of product requirements for packaging, medical devices and delivery systems such as drug/device combination
- Monitoring work progress according to plan along with supporting and challenging technical development as well as testing and verifying work
- Implementing and manufacturing processes as well as managing the collaboration with internal development partners and stakeholders
- Providing primary packaging and device expertise in a broader cross-functional drug product development team in compliance with evaluating and challenging technical solutions
- Conducting the manufacturing of clinical material and the production scale up
- Leading Human Factors Engineering activities and managing Risk management activities
- Transferring of Design History File to production along with planning design verification activities and ensuring a high quality
Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH14155
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…