Medical Device Project Leader

Medical Device Project Leader wanted for our Basel based client in the pharmaceutical sector.

YOUR EXPERIENCE/SKILLS:

- University degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education
- 7 + years' work experience in leading device development technical teams or in a similar area along with profound background in Project and Program Management
- Know-How of pharmaceutical development in general and Medical Device Regulations such as FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation
- Competency in developing and writing of technical documentation, in drug/device combination products and medical devices as well as in Design Control process and other applicable regulatory, QA and GMP aspects
- Good command of managing external suppliers, Product Design or Design for Manufacture and of test and verification, including development of methods and equipment
- General understanding of Human Factors Engineering, clinical studies processes, risk management and requirements
- Languages: fluent English both written and spoken, German and French would be an advantage

YOUR TASKS:

- Conducting the definition of product requirements for packaging, delivery systems and medical devices such as drug and device combination products
- Observing work progresses and supporting technical development including test and verification work as well as controlling the development and implementation of manufacturing processes
- Supplying primary packaging and device expertise in a broader cross-functional drug product development team as well as managing the collaboration with external development partners
- Supporting and coordinating the manufacturing of clinical material and the production scale up
- Providing support to cross functional project teams in the development, review and submission of regulatory dossiers along with monitoring Human Factors Engineering activities
- Managing and securing Risk management activities, design verification activities and technical documentations
- Maintaining high quality of Design History File and transferring it to production

START: 10/2018
DURATION: 06MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13522

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.

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