Software as a medical device

Now we are looking for you who want to be part of making a difference in people's lives by working as a consultant in Life Science! Here you are involved in developing the future of the pharmaceutical and medtech industry.

At Semcon, you will have a leader who supports your development and you will be part of a team who works with different types of projects within the Life Science industry. We always look into the needs and behaviors of the end-user when we develop products & services. You will work together with skilled colleagues, interesting companies and get the opportunity to take on different assignments and roles.

Depending on the assignment, we work with software as a medical device, validation of processes, GAP analyzes, classification and release of medical technology products. We work according to MDD / MDR, ISO 13485, Design Control, 21 CFR 820 and different QMS. We perform quality controls (QC) and GxP audits.

What you will work with:

- Define high level requirements for electrical equipment/products/apps

- Create system architecture and define system level properties

- Product design and define product properties

- System integration and verification

- Design Verification of electrical equipment/products/apps and systems

- Usability and Design Validation of electrical equipment/products/apps and systems

You bring with you:

You have a good understanding of Medical electrical device, System architecture and CEmark of apps in several of the areas listed below. You communicate well and thrive in a dynamic workplace.

- Application of IEC 62304 or IEC 82304-1

- Software development planning and estimation

- Software architecture and safety segmentation

- Software requirements definition

- Unit, integration and system-level testing

- Automated tools for testing and integration

- Safety risk management

- IEC6060

- Great communication skills in Swedish and English


As a colleague, you are driven by personal development, thrive in an eventful workday and have an open and positive mindset. You enjoy problem solving and has a tendency to turn challenges to creative solutions. You see possibilities and are eager to help where needed.

We strongly believe that diversity of background, experience and perspectives is important to create excellent user experiences and to make Semcon a great place to work.

If you are interested in joining our team, just apply with your CV or LinkedIn below, or contact Tran to learn more!

Tran Cam
Area Manager Digital Services
tran.cam@semcon.com

We look forward to your application!