Medical Device Project Leader

For our client in BASEL we are looking for a MEDICAL DEVICE PROJECT LEADER for a 6-MONTHS contract.

JOB TITLE: MEDICAL DEVICE PROJECT LEADER

DURATION: 15/10/2018 TO 14/04/2019 (extension possible)

LOCATION: BASEL

WORKLOAD: 90%

DESCRIPTION:

The successful candidate for this position will need to be able to lead the technical development of packaging and/or drug delivery systems within 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.

MAIN TASKS:

. Thorough project planning
. Provide primary packaging and device expertise in a broader cross-functional drug product development team
. 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

Other tasks:

. Leading the definition of product requirements for packaging, medical devices, delivery systems, eg 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
. 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

EDUCATION REQUIREMENTS:

. 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.

EXPERIENCE REQUIREMENTS:

. 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
. 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 understanding of pharmaceutical development in general
. Experience in project/program management of complex projects
. Considerable experience of managing external suppliers
. Good communication and conflict solving skills
. Proficiency in German/French will be advantageous.

For further details please contact:
Anna Undas
(see below)