Disclaimer

The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed.
The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe.

Open positions

We are a pioneer in treating drug-resistant fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. alfapump® and DSR® are Sequana Medical’s proprietary approaches that work with the body to remove this excess fluid, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. We are listed on Euronext Brussels, headquartered in Ghent, Belgium and also have offices in Zurich, Switzerland.

We embrace diversity and inclusion. You will have the opportunity to work with outstanding business teams and contribute to the success of the company. We strive to provide all our employees with the means to develop their skills and experiences, at every level.

Medical Device Engineer Software (Zürich and Munich – 100%)

As a part of the engineering team, the person in this position acts as subject matter expert for medical device software. Manages the requirements from start (User requirements) to validation. Manages changes of software as part of our production environment and our product’s life-cycle management. Conducts software verification and validation according to the guidance of the Regulatory Affairs department. Manages R&D projects meeting timelines and budget. Supports other departments in technical matters. A motivated, self-organizing individual with strong analytical and communication skills.

Key Responsibilities:
  • Subject matter expert for medical device software
  • Creation and management of requirements from start to validation.
  • Writes change requests of software as part of our production environment and our product’s life-cycle management in close collaboration with the regulatory and manufacturing team
  • Creation and maintenance of the technical documentation on engineering matters throughout the life-cycle of product components of an active implantable medical device system in accordance with the company’s quality management system
  • Software verification and validation according to the guidance of the Regulatory Affairs department
  • Support the Regulatory and Quality Affairs team in technical matters
  • Technical performance and root-cause analysis of software used in product components or engineering and manufacturing test equipment
  • Software development according to IEC 62304 standard
  • Management of internal and external resources within software development projects
Key requirements:
  • Good understanding of medical device development process.
  • Familiarity with ISO13485, FDA 21CFR820  and IEC 62304
  • Proficient with software design, code development, code review and software release
  • Experience in application development in C#, SQL database.
  • Strong analytical skills
  • Ability to formulate complex technical content in an understandable way and according to regulatory guidance
  • Ability to work well independently and cross-functionally as part of an established team
  • Strong communication skills both verbally and in writing
  • Organized, reliable, attention to detail
Nice to have:
  • Experience in cloud development
  • Experience in python and cybersecurity in medical devices are beneficial.
Required Education / Experience:
  • BSc or equivalent degree in computer science engineering or related
  • Minimum of 3 years experience in software development
  • Minimum of 2 years’ experience in a medical device or highly regulated industry

We offer a full time (100%) contract in a very dynamic and international environment with an attractive salary package at our Zürich and Munich offices.

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

 

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