For our customer located in Basel, St. Johann/Switzerland we are currently looking for (m/f) a Medical Device Development Project Leader
• Type of placement: 6 months, external contract with possible long term extension
• Company: major Pharma company in Basel area
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 of our customer, 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.
- Start: asap
- Duration: initial 6 month, with extension possible
Tasks and responsibilities would typically include
- 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
Bachelor’s or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education.
An ideal candidate would have a relevant degree in engineering and at least 7 years’ 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
- Considerable experience of managing external suppliers
- Mechanical engineering in general
- - Product design/Design for manufacture
- - 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
Kindly be informed that this job offer is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.
Please attach your CV in Word format.
SimplyVision is looking forward to your application.