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
Operational Excellence Specialist Medical Devices
Reporting into Bastian Perroset, Head of Operations
Responsibilities
- Lead and facilitate manufacturing process improvement projects at customers using methodologies such as Lean, Six Sigma, or other relevant frameworks
- Use simulation techniques such as Simio to model and optimise manufacturing processes and operations
- Identify and prioritise opportunities for process improvement and optimisation across the customer’s organisation
- Collaborate with cross-functional teams at the customer and with external partners to identify and implement best practices in operational excellence
- Solve problems and find solutions with the right balance between state-of-the art technology, business needs and compliance
Skills & Experience
- Education in engineering or natural science at least Master of Science (MSc)
- At least 5 years of experience in process engineering and production environment of (active) medical devices or in-vitro diagnostics
- Experience with production planning and process simulation software (e.g. Simio)
- Proven experience with Lean, Six Sigma, or other process improvement methodologies
- Strong analytical and problem-solving skills
- Excellent communication and project management skills
- Proficient in process mapping and data analysis software, MS Office, and other relevant tools
- Six Sigma Green or Black Belt certification is preferred
- Strong leadership skills, able to lead and manage cross-functional teams and lead projects effectively
- Hands-on attitude
- Ability to gain the trust of various stakeholders
- Fluent in English and German
Benefits
- You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
- You will 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
To find out more and apply for this role, visit our LinkedIn jobs page.
SME Connected Medical Devices & Software as Medical Device (SaMD) incl. Cybersecurity
Reporting into Paul Gardner, Head of eHealth
Responsibilities
- Technical leadership of development of connected devices (HW/FW) and development of mobile and/or web applications classified as SaMD
- Lead systems engineering and risk management activities including cybersecurity for connected medical devices and SaMD
- Plan and monitor design verification activities
- Lead and author technical documentation (DHF / DMR)
- Technical leadership of the development and adoption of cybersecurity policies and processes for medical devices in the EU & US
- Be a security subject matter expert and respond to any security questions/requests, specialised in product security
- Be a technical consultant to other members of the customer’s organisation and customer’s customers, in all areas of system and software design including security and privacy, providing detailed analysis, feedback, and other assistance as required
- 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
Skills & Experience
- BSc / MSc (desirable) in a relevant field
- Autonomous and independent working style with at least 5 years’ experience of projects with safety critical injection devices and related applications in a regulated environment
- Team player who works efficiently in interdisciplinary teams
- Analytical thinking and problem‐solving capability
- Excellent understanding of SW Lifecycle Management IEC 62304, Electrical Safety IEC 60601-1, Risk Management ISO 14971 as well as in Cybersecurity, Data Privacy and Data Protection
- Understanding of medical device regulations (EU Medical Device Regulation 2017/745, FDA 21CFR 4)
- 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).
- Fluent in English and German (desirable)
Benefits
- You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
- You benefit from flexible working hours and an exciting and versatile field of activity
- You will work in a company with a flat hierarchy, with short decision-making processes
- You can expect a pleasant working atmosphere, with uncomplicated and collegial cooperation
- You will benefit from modern and attractive working conditions and development opportunities
- An attractive salary and very good social benefits round off the offer
To find out more and apply for this role, visit our LinkedIn jobs page.
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