Disclaimer

Das alfapump®-System ist derzeit weder in den Vereinigten Staaten noch in Kanada zugelassen. In den Vereinigten Staaten und Kanada befindet sich das alfapump®-System gegenwärtig in der klinischen Prüfung (POSEIDON-Studie) und wird bei erwachsenen Patienten mit refraktärem oder rezidivierendem Aszites aufgrund von Zirrhose untersucht. Weitere Informationen zur klinischen Studie POSEIDON finden Sie unter www.poseidonstudy.com.
Die DSR®-Therapie befindet sich aktuell in der Entwicklung, und es ist zu beachten, dass alle Aussagen in Bezug auf Sicherheit und Wirksamkeit auf laufenden präklinischen und klinischen Untersuchungen beruhen, die noch nicht abgeschlossen sind.
Die DSR®-Therapie ist derzeit in den Vereinigten Staaten oder Kanada nicht zur klinischen Forschung zugelassen. Es gibt keinen Zusammenhang zwischen der DSR®-Therapie und laufenden Untersuchungen mit dem alfapump®-System in Europa.

Open positions

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.

Manufacturing Planner (Zürich – 100%)

As a manufacturing planner you assist /cooperate closely with the manufacturing and supply teams to give visibility for the entire process of components sourcing through production forecasting and roll out of finalized products into the market. You support the supply chain director and production manager for the material availability for production and logistics of the alfapump®, an implantable Medical Device for the automatic and continual removal of ascites in patients with liver disease.

To be able to master this challenge, you keep a professional and open relationship to multiple key internal stakeholders, collaborating closely with internal departments to ensure availability of the material in a timely manner.

You are part of the Manufacturing/Supply Chain department, which is crucial to guarantee product availability on commercial markets and in clinical trials.

Key Responsibilities:
  • Master data management;
  • Provide project management support for the function;
  • Liaise with internal teams and sales divisions to determine production demand;
  • Plan production runs and schedules according to internal and external demand;
  • Develop and review production plan with Manufacturing/Supply Chain leadership;
  • Monitor execution of production plan and work with manufacturing team to resolve potential issues in a timely fashion;
  • Plan inventory management process to avoid shortages;
  • Monitor execution of inventory management and work with supply chain team to resolve potential issues in a timely fashion;
  • Escalate complex issues to Manufacturing/Supply Chain leadership for resolution;
  • Plan material requirements to execute manufacturing plan;
  • Coordinate with Managers in planning and implementing inventory-related changes in production.
Key requirements:
  • Bachelor’s degree in Supply Chain Management, Business Management, or related field is preferred;
  • Proven experience as a production planner;
  • Experience working on highly regulated environments: healthcare (pharma/medical devices), food, …;
  • Experience in material requirements planning (MRP);
  • Working knowledge of MS Office and ERP systems;
  • Project management experience a plus;
  • Good at maths and statistics;
  • Detailed oriented, strong analytical and problem-solving skills;
  • Effective communication skills;
  • Proficient oral and written skills in German and English.
Required Education / Experience:
  • Technical degree with further education in purchasing, supply chain or similar, Project Management;
  • 5 years of experience as a planner or project manager in a technical environment and/or supply chain;
  • Relevant experience with Supplier Relationship Management and ERP systems;
  • Work experience in a highly regulated industry (Medical Device, GMP, FDA, ISO 13485) is a plus.

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

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

Manager of Engineering & Development (Zürich – 100%)

Leads the Engineering & Development department of Sequana Medical to ensure timely delivery of hardware and software components including their technical documentation for new products and system components, product improvements and production test systems based on user and process requirements. Ensures full compliance of engineering activities and technical documentation with the company’s quality management system. Supports the manufacturing team in ensuring product availability for the planned lifetime. Supports the manufacturing, sales and clinical team in all technical aspects.

Key Responsibilities:
  • Team leadership based on a culture which ensures supportive, productive working relationships with fact-based decision making;
  • Management of the engineering team and external partners to meet defined timelines and company goals;
  • Overall responsibility for hardware, firmware and software development for new products and system components, product improvements and production test systems;
  • Requirements engineering and technical design specification;
  • Product verification strategies and implementation (specification, planning, testing, documenting);
  • Creation and maintenance of technical documentation;
  • Supports Component life cycle management;
  • Implementation and maintenance of processes for engineering activities in collaboration with QM/QA/RA department;
  • Internal technical support and training;
  • Send out Technical Reports (e.g. DirectLink) in collaboration with RA to customers;
  • Root cause analysis of nonconforming products, systems and components.
Key requirements:
  • Demonstrated ability to develop a “hands-on” approach, requiring personal initiative and responsibility while operating at a high level of performance and efficiency;
  • Proactive and hands-on ability to lead the engineering activities required to meet Sequana Medical’s engineering objectives;
  • Demonstrated ability to operate in a venture capital backed company environment with the entrepreneurial drive to proactively participate to the engineering activities required to meet Sequana Medical commercial objectives;
  • Demonstrated ability to manage engineering in a medical device industry or in other highly regulated environments;
  • English and German in reading and writing;
  • Demonstrated ability to lead and motivate a team.
Required Education / Experience:
  • Master’s degree in medical device engineering, mechatronics engineering or similar;
  • Experience in the medical device industry including hard- and firmware / software development;
  • Development experience in the field of embedded systems or software preferable;
  • More than 3 years team leadership experience.

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

Medical Device Engineer Electronics (Zürich – 100%)

Sequana Medical NV is looking for a Medical Device Engineer Electronics (Zürich –
100%).
Acts as subject matter expert for medical device electronics. Creates and maintains the
design history file owned by the Engineering department. Monitors, plans and manages
changes of electronics as part of our product’s life-cycle management. 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:
  • Subject matter expert for medical device electronics / embedded systems;
  • Life-cycle management of electronics components of an active implantable medical device system;
  • Writes changes requests of electronics as part of 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;
  • 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:
  • Proficient with digital and analog circuit design;
  • Proficient with CAD software for schematics and PCB layout design;
  • 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;
Qualifications and Position Requirements:
  • MS or equivalent degree in electrical engineeringg;
  • Minimum of 5 years R&D experience in a highly regulated industry;
  • Minimum of 3 years experience in medical device development;
  • Experience or strong theoretical knowledge in analog and digital signal processing and circuit design;
  • Experience in Firmware development;
  • Experience with low-power, battery operated embedded systems;

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

Medical Device Engineer Mechanical (Zürich – 100%)

Sequana Medical NV is looking for a Medical Device Engineer Mechanical (Zürich – 100%).
Acts as subject matter expert for medical device mechanics. Creates and maintains the design history file owned by the Engineering department. Monitors, plans and manages changes of mechanics as part of our product’s life-cycle management. 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:
  • Subject matter expert for mechanical parts of a medical device systems;
  • Life-cycle management of mechanical components of an active implantable medical device system;
  • Writes changes requests as part of 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;
  • Responsible for Solidworks CAD Systems;
  • Responsible for maintaining the technical drawings;
  • 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:
  • Proficient with mechanical design;
  • Proficient with CAD software Solidworks;
  • 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;
  • Qualifications and Position Requirements;
  • MS or equivalent degree in mechanical engineering;
  • Minimum of 5 years R&D experience in a highly regulated industry;
  • Minimum of 3 years experience in medical device development;
  • Experience in industrialization and manufacturing processes;

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

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