Medical Device Expert Software

We make innovation happen!

Effectum Medical is breaking new ground in the areas of quality management and regulatory affairs in the medical device industry. Our mission is to support efficient, accelerated market access to medical device innovators. We strive to become the industry state-of-the-art solution for a plug-and-play QMS and outsourced Legal Manufacturing.

Our customers are start-ups, SMEs, as well as globally operating companies. Conceptual thinking combined with pragmatism make us a strong partner who knows what really matters.

To further grow our company, we are looking for a

Medical Device Expert Software (80-100%)

to join our team.

In this position

• Your primary focus will be on projects involving medical software and active medical devices/IVDs with embedded software across all risk classes.
• You will collaborate with customers, ranging from start-ups to teams within global corporations, to refine their technical documentation to meet the requirements for CE marking or FDA approval.
• Your responsibilities will include reviewing, approving, and contributing to the establishment of technical documentation.
• You will effectively track projects, monitor progress and budget, and adjust plans and timelines as needed to align with the customer and project partners.
• You will guide project team members through the Quality Management System (QMS) and ensure compliance with processes required for the development and lifecycle management of medical devices, including software.

You

• are a proactive, pragmatic, hands-on professional who thrives on taking initiative, delivering results, and contributing ideas and suggestions to drive continuous improvement.
• have 5+ years professional experience with Technical Documentation for medical software and/or active medical devices/ IVD with embedded software and have obtained product certification.
• have experience in a consulting environment, providing innovative solutions and adapting to dynamic client needs, is highly advantageous.
• have knowledge of ISO 13485, MDR, IVDR, QMSR 21 CFR Part 820[KC1] [MW2] [CM3] , IEC 62304, IEC 60601-1, ISO 14971, ISO 27001 and the certification processes for medical devices in Europe and the USA for medical software and/or active medical devices/ IVD with embedded software. Knowledge of other territory/regulatory requirements beneficial.
• 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 guide our customers and share your knowhow to get the best possible results.
• have strong project management skills, ensuring projects are delivered on time, within scope, and within budget.
• have a proven track record of managing budgets with precision ensuring financial targets are met.
• have demonstrated ability to effectively manage multiple projects simultaneously.
• have excellent knowledge of English, written and spoken, and good conversational skills in German.

We offer

• We have a broad spectrum of customers and products – from software products to active and non-active devices, as well as IVD products, making this a challenging and fun position!
• 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 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).

Please note that we only accept direct applications (no recruitment companies) and only complete applications will be considered.