Join our Team
As our customer base and service portfolio continue to develop and grow, we welcome applications from experienced candidates looking to join our dynamic organisation.
If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the medical technology industry, then a role as a Congenius Consultant could be your next rewarding career step. Get in touch to find out more about joining the team.
Current opportunities
SME Connected Medical Devices & Software as Medical Device (SaMD) incl. Cybersecurity (m/f/d, 100%)
Reporting into our Head of Quality Dirk Hüber
Your responsibilities
- Technical leadership of development of embedded software for connected devices (SiMD) and/or development of mobile and/or web applications classified as SaMD
- Technical leadership of the development and adoption of cybersecurity policies and processes for medical devices in the EU & US
- Lead systems engineering and risk management activities including cybersecurity for connected medical devices and SaMD
- Lead and author technical documentation (DHF/DMR) for connected medical devices and SaMD
- Maintain proficiency in current technology, design practices, architectures, software and networking processes, tools, and methods; make recommendations regarding the implications and application of these advances
- Interaction with Contract Development Partners (CDOs) regarding development of SaMD
- Advise and consult customer (take indirect leadership as appropriate)
Your skills & experience
- BSc / MSc (desirable) in a relevant field
- Excellent understanding of ISO 13485, SW Lifecycle Management IEC 62304 & IEC 82304-1, Risk Management ISO 14971 as well as Cybersecurity ISO/IEC 27001, ANSI/AAMI SW96, AAMI TIR 57/97
- Understanding of medical device regulations (EU Medical Device Regulation 2017/745, FDA FD&C Act)
- Strong experience in security and privacy in software and embedded (preferably regulated medical) systems
- Deep knowledge and experience with systems engineering, security and privacy techniques and practices (threat modelling, risk analysis, encryption design and authentication methods, de-identification, key management, etc)
- Initial experience in the application of Artificial Intelligence/Deep Learning /Machine Learning in a regulated environment is an advantage
- Autonomous and independent working style with at least 5 years’ experience of projects with safety critical medical devices and related applications in a regulated environment
- Team player who works efficiently in interdisciplinary teams
- Analytical thinking and problem‐solving capability
- Fluent in English and German (desirable)
Benefits
- You’ll work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
- You’ll benefit from flexible working hours and an exciting and versatile field of activity
- You’ll work in a company with a flat hierarchy, and short decision-making processes
- You can expect a pleasant working atmosphere, with uncomplicated and collegial cooperation
- You’ll benefit from modern and attractive working conditions and development opportunities
- An attractive salary and very good social benefits round off the offer
You can apply for this role via our LinkedIn jobs page.
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