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.
* 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 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
· 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
· Team player who works efficiently in interdisciplinary teams
· 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
· 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: Luchele Mendes +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.