Senior System Engineer with focus on Software as a Medical Device (SaMD)
80-100%Zurich - Switzerland
Bern - Switzerland
Product EngineeringWhat drives us
At Zühlke, you are where innovation happens. We focus on teamwork, agile collaboration, and leading technologies to shape the future and challenge the status quo. We like to break down barriers and explore new territory. This is how we innovate.
Our creativity, our skills and our energy enable us to turn intelligent ideas into valuable solutions – solutions that help our clients bring innovative, effective, and sustainable products, solutions, and processes to the marketplace. At Zühlke, we are driven by «empowering ideas».
How you will spend your time
In this role, you will lead the development and lifecycle management of complex products and platforms in the areas of networked drug delivery devices and software as a medical device. In doing so, you use modern systems engineering approaches.
You are responsible for requirements management, implementing risk management at system level and coordinating risk management activities at component level. Furthermore, you plan and implement integrated verification and validation activities for the system design. Finally, you actively maintain and monitor traceability from requirements to verification activities.
You want to make an impact – With your quality awareness and communication skills, you will be able to successfully implement the client's vision despite challenging circumstances in a regulated environment. Your solutions can consist of physical medical devices, mobile apps, and cloud-based data storage.
Communication is your strength – In order to successfully develop medical devices, you prove strong technical ability at system level and guide the project teams in analyzing users’ pain points and needs, requirements elicitation and systems modeling to define features and reusable components. You structure and visualize the system using latest systems modelling tools.
You have a growth mindset – building on a comprehensive education offering, you continuously keep up to date with modern technologies and development practices and apply them in projects to build your expertise. You continuously expand your excellent problem-solving skills and analytical mindset. Empowered by a network of highly skilled peers and experts, we support you in your individual career planning. Whether it is becoming an expert in your field or growing your leadership or consulting skills and progressively taking more responsibility in your projects.
What is important to us
- You are well-versed in medical device and/or SaMD development from concept to commercial launch. You know Quality Management Systems and regulatory processes (ISO 13485; 14971, IEC 60601, 62304, 82304).
- You have detailed knowledge of requirements and traceability management tools, previous experience of Polarion is an advantage.
- Knowledge of industry best practices in software development: methodology (Agile and V-model) and tooling (CI/CD, automation, requirements management) as well as modelling (UML/SysML).
- Experience with cyber security, data protection and system performance requirements are a plus.
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines.
What working at Zühlke is all about
- Highly interactive role – you will work with cross functional teams to develop platform architectures that can be used across multiple products. You are the representative of system engineering within teams, programs, and stakeholders.
- Unique culture - we communicate openly with each other, assess ourselves honestly and enjoy working in a team.
- Further development – we invest 10% of our turnover in the development of our employees. We help you grow through continuous, high-quality training.
- Knowledge exchange - we have an interdisciplinary approach, culture of knowledge sharing and learning from each other.
- International topic groups – we exchange experience, knowledge and support each other in our further development within our internal communities
- Great workplace – we offer a culture of trust, encourage you to think creatively and to share your ideas.
We are all learning all the time
Do you feel that you do not yet meet all the requirements? We would like to know more about you, your ambitions and ideas and look forward to receiving your application!
Sounds like a great way to work?
Zurich , Bern