Medical Device Project Leader
Recruiter
RM IT Professional Resources AG
Listed on
27th February 2019
Location
Basel
Salary/Rate
Negotiable
Salary Notes
Negotiable
Type
Contract
Start Date
04/2019
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Medical Device Project Leader 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...
