Beschreibung
For our Medical Device Company we are recruiting for an expert in App Development to support their expanding development of "Software as a Medical Device" (SaMD) You will be a recognized expert for the development and maintenance of safety critical mobile and/or web applications and will take over the technical leadership for the software development part for projects classified as SaMD within the Packaging & Device Development Team.Responsibilities:
- The role includes early phase development activities, the management and monitoring of software development at external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer.
- 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: Selection, management, overview of suppliers.
- Support the deployment and implementation of a sustainable Product Life Cycle process
- 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 and 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; Excellent understanding of software design and programming principles as well as in overall verification strategies, including test set?up and test automation
- 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
- In addition to outstanding project management and interpersonal skills, a strong background in software development and lifecycle management, as well as the use and implementation of platform technologies, is crucial for this role. The successful candidate will play a critical role in the support and sustainable expansion of the SaMD area.
Kontact: or call
Michael Bailey International is acting as an Employment Business in relation to this vacancy.