Beschreibung
For our client in Basel (Switzerland), we are looking for a App Development Team Leader for 1 year contract.
Location: Basel
Duration: to
Workload: 100%
The role includes early phase development activities, the management and monitoring of software development with the external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer. In addition to outstanding project management and interpersonal skills, a strong background in software development and life cycle management, as well as the use and implementation of platform technologies, is crucial for this role. There will be no coding - software development is made by external partners.
Tasks and responsibilities will typically include:
- Technical leadership for the software development of mobile and/or web applications classified as
SaMD
- Providing software/systems life cycle expertise within a broader cross functional drug product
development team
- Supporting the standardization of the entire SaMD life cycle management process in order to
utilize cross product synergies
- Leading the collaboration with external development partners:
- Support supplier selection, auditing and approval
- Elaboration of development plans and contracts for upcoming projects
- Monitor work progress according to plan
- Monitor, support and challenge technical development and deliverables as well as change,
test and release strategies
- Support the deployment and implementation of a sustainable Product Life Cycle process in
close collaboration with external and internal partners and stakeholders
- Leading and/or supporting cross functional project teams during development, review and
submission of regulatory dossiers
- Leading risk management activities
- Planning and monitoring of design verification activities
- Leading and authoring technical documentation
- Ensuring a high quality Design History File
- Supporting the improvement of the SaMD QMS
Requirements:
- MSc/MA in computer science or relevant field
- Excellent understanding of the current Agile development methods and technologies
- Experience in project/program management of complex projects
- Autonomous and independent working style with at least 7 years of experience as technical
project management of projects with safety critical applications in a regulated environment
- Experience in designing innovative software and systems architectures
- Analytical thinking and problem solving capability
- Excellent understanding of software design and programming principles as well as in overall
verification strategies, including test set up and test automation
- Good communication and conflict management skills
- Considerable experience of managing external suppliers
- General understanding of Human Factors Engineering, risk management and clinical studies
processes and requirements
- Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical
Device Directive, EU Medical Device Regulation), including those related to medical software (IEC
62304)
- Development and writing of technical documentation of drug/device combination products and
medical devices, including the design control process and other applicable regulatory, QA and
GMP aspects
- Understanding of pharmaceutical development in general
- Fluency in English language incl. technical writing Experience desired
- German would be an asset
For further details please contact Mateusz Czarnocki
e-mail: (see below)
Telephone: (see below)