23. April 2021
We are hiring
Effectum Medical is a young company that is breaking new ground in the areas of quality management and regulatory affairs in the medical device industry. Our vision is to facilitate and accelerate medical device product innovation by offering an affordable, outsourced quality management system (QMS) and legal manufacturing. Our customers are start-ups, as well as global medical device manufacturers.
To further grow our company, we are looking for a
Junior Project Manager Medical Devices – 80-100%
to join our team.
In this position
- You will manage medical device projects of our customers, which are start-ups and project teams from global players, for their EU & FDA registration and therefore play a key role in making their projects a success.
- You will support our customers in bringing the technical documentation to the point where they can obtain the CE mark (or FDA approval). Depending on the customer, you will review, approve, or also write parts of the technical documentation.
- You will suggest and implement improvements to our QMS and processes.
- Your main focus will be projects in medical software and active medical devices with embedded software of all risk classes.
- at least 2 years of professional experience in the medical device industry.
- successfully lead development projects for medical software and/or active medical devices with embedded software and obtained certification.
- knowledge of ISO 13485, MDD, MDR, 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 with embedded software.
- ideally, an education in software and/or hardware development, however a technical flair is a must.
- a customer focused approach to coordinate and supervise stakeholders.
- excellent knowledge of English, written and spoken, and good conversational skills in German.
- the possibility of working in a motivated team with a common goal – accelerating innovation in the medical devices industry.
- flexibility – our offices are located in Olten, 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? 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).