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Sequana Medical NV is a commercial stage medical device company with headquarters in Ghent, Belgium and offices in Zurich, Switzerland. At Sequana Medical, we are committed to helping patients suffering from fluid overload due to liver disease, malignant ascites and heart failure. Sequana Medical’s technology is based on its proprietary alfapump® platform, a subcutaneously implanted battery-powered pump that ensures the controlled and continuous removal of fluid from the abdominal cavity into the bladder where it is eliminated through urination.
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 (Zürich - 100% workload)

Creates and maintains the design history file owned by the Engineering department. Manages technical changes as part of our product’s life-cycle management in accordance with the company’s quality management system. Conducts product component verification. 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:

Creation and maintenance of the technical documentation on engineering matters throughout the life-cycle of product components of an implantable medical device system;
Write product change requests in close collaboration with the regulatory and manufacturing team;
Support the Regulatory Affairs and Quality team in technical matters;
Product component verification activities;
Technical performance analysis of products in the field;
Failure root-cause analysis of returned products, non-conformities in production and devices under test;
Management of internal and external resources within development projects.

Key requirements:

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.

Required Education / Experience:

MS or equivalent degree in biomedical, mechanical or electrical engineering;
Minimum of 5 years R&D experience in industry, at least 3 years in the medical industry;
Experience in medical device development according to regulatory requirements.

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

Apply now

Medical Device Engineer Software (Zürich – 100%)

Acts as subject matter expert for medical device software. Creates and maintains the design history file owned by the Engineering department. 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;
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.

Key requirements:

Proficient with software design, code development, code review and software release;
Proficient with Integrated Development Environments and software release management;
Experience with build servers and software test platforms;
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;
MS or equivalent degree in software engineering;
Minimum of 5 years software development experience in a highly regulated industry;
Minimum of 3 years experience in medical device software development;
Experience in firmware development in C/C++ and application development in C#.

Required Education / Experience:

MS or equivalent degree in software engineering;
Minimum of 5 years software development experience in a highly regulated industry;
Minimum of 3 years experience in medical device software development;
Experience in firmware development in C/C++ and application development in C#.

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

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

Apply now