Beschreibung
- As a modern company, our client manages to constantly develop further and break new ground
Lead Expert App Development NOVJP (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Technical leadership for the software development of mobile and/or web applications classified as Software as Medical Device (SaMD)
- Providing software/systems life cycle expertise within a broader cross-functional drug product
- Supporting the standardization of the entire SaMD life cycle management process in order to
- Utilize cross-product synergies
- Leading collaboration with external development partners including support of supplier selection, auditing and approval
- Elaboration of development plans and contracts for upcoming projects
- Monitor, support and challenge technical development and deliverables as well as change,
- Test and release strategies
- Support deployment and implementation of a sustainable Product Life Cycle process
- 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 and leading and authoring technical documentation
- Planning and monitoring of design verification activities
Main qualifications
- MSc/MA in computer science or relevant field and excellent understanding of the current agile methods
- Autonomous and independent working style
- Experience in 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
- Experience in 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
- Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical
- Knowledge of Device Directive, EU Medical Device Regulation), including those related to medical software (IEC 62304)
- Fluency in English language incl. technical writing experience desired, proficiency in German
Main advantages:
- A very renowned company
- You will work in an international environment
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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