Consultant - 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 Quality Management, we lead and implement qualifications of equipment and systems. We develop and review quality and regulatory documents in medical technology, in cosmetics and in foodtech.

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

Development using agile methodologies

Safety risk management

IEC60601

At Semcon, you will have a leader who supports your development and you will be a part of a team who work with different types of projects within the broad spectra of Life Science. Your opinion and knowledge are important. We always look into the needs and behaviors of the end-user when we develop products & services. We take initiatives based in curiosity and are proactive and communicative towards our customers and colleagues.

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.

Interested? Apply today!

Do you have any questions or want to learn more about the position? Contact Erika Palm at erika.palm@semcon.com

We look forward to your application!