Duration: 01/02/2019 to 31/12/2020
Medical Device / Packaging development Project Leader
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.
Tasks and responsibilities would typically include:
* Leading the definition of product requirements for packaging, medical devices, delivery systems, e.g.be developed
* drug/device combination products in which the device is generally already registered but sometimes to
* 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 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 or Packaging development technical teams in a similar area
* Fluency in English language incl. technical writing.
* Proficiency in German/French advantageous.
* 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 Provides work direction and assigns tasks to lower level employees.
* Ability to manage the results and budgets of multiple complex IT projects that are high in complexity, size, and scope.
* Ability to manage enterprise wide IT issues, conflicts, risks, and deliver projects within budget and scope.
* Develops and maintains long-term relationships with strategic customers and industry leaders.
* Experience in Quality Assurance management, concepts, and application
* Good understanding of pharmaceutical development in general
* Experience in project / program management of complex projects Considerable experience of managing external suppliers
* Mechanical engineering in general: Product design/Design for manufacture
* General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements
* Good communication and conflict solving skills
Should you be interested in this or similar within Medical Devices, please feel free to get in contact with me or send me your latest CV
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