21. June 2022
New Opportunity to join the Effectum Team!
To further grow our company, we are looking for a
Expert Technical Documentation Medical Device Software (80-100%)
to join our team.
In this position
- Your main focus will be projects in medical software and active medical devices/ IVD with embedded software of all risk classes.
- You will support our customers, which are start-ups and project teams from global players, in bringing their technical documentation to the point where they can obtain the CE mark (or FDA approval). You will review, approve, and occasionally also write parts of the technical documentation.
- have 3+ years professional experience with Technical Documentation for medical software and/or active medical devices/ IVD with embedded software and have obtained certification.
- knowledge of ISO 13485, MDR, IVDR, QSR 21 CFR Part 820, IEC 62304, IEC 60601-1, and the certification processes for medical devices in Europe and the USA for medical software and/or active medical devices/ IVD with embedded software.
- ideally, have an education in software and/or hardware development. However, a good understanding of the software development process, software risk management, verification and validation strategies is a must.
- value and enjoy teamwork and working with different project teams and are eager to coach our customers and share your knowhow to get the best possible results
- have a pro-active attitude and willingness to bring in ideas and suggestions to support continuous improvement
- have excellent knowledge of English, written and spoken, and good conversational skills in German
- A new challenge! We have a broad spectrum of products – from software products to active and non-active devices, as well as IVD products – and customers, making this a challenging and fun position!
- The possibility of working in a motivated team with a common goal – accelerating innovation in the medical device industry.
- Flexibility – our offices are located in Olten only minutes by foot from the train station; partially working from home is possible.
- The ability to actively shape and further develop the company with us to reach our common goal.
- Personal development opportunities in a growing company.
Do you share our vision to facilitate and accelerate medical device product innovation by offering a plug-and-play QMS and outsourced legal manufacturing? If the answer is “YES!” we are looking forward to getting to know you.
Please send your full application (CV, motivational letter, work certificates & diplomas) to anne.marie.joller(at)effectummedical.com
Please note that we only accept direct applications (no recruitment companies) and only complete applications will be considered.