14. January 2025

New opportunity – Medical Device Expert Software 80 -100%

We are currently looking for a

Medical Device Expert Software (80-100%) 

to join our team.

 

In this position you

• 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 , 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) to Marius Wiederkehr, Head of Legal Manufacturing Services at marius.wiederkehr(at)effectummedical.com 

Kindly indicate your salary expectations and your availability/notice period in your application.

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

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