Disclaimer

Actuellement, le système alfapump® n’est pas approuvé aux États-Unis ou au Canada. Aux États-Unis et au Canada, le système alfapump® se trouve actuellement en phase d’examen clinique (étude POSEIDON), et il est étudié sur des patients adultes souffrant d’ascites réfractaires ou récurrentes dues à une cirrhose du foie. Pour de plus amples informations concernant l’étude clinique POSEIDON, cf. www.poseidonstudy.com.
Le traitement DSR® (élimination directe de sodium) se trouve encore en phase de développement, et il convient de tenir compte du fait que toute déclaration concernant la sécurité et l’efficacité émane d’examens pré-cliniques et cliniques en cours, ceux-ci n’ayant pas encore été finalisés.
Actuellement, le traitement DSR® n’est pas approuvé pour la recherche clinique aux États-Unis ou au Canada. Il n’y a aucun lien entre le traitement DSR® et les examens avec le système alfapump® en cours en Europe.

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.

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

Demand and Supply Planner (Zürich – 100%)

As a demand and supply planner, you cooperate closely with the sales, manufacturing and supply teams to ensure high service level by availability of products at optimal inventory levels with maintaining good forecast accuracy and low forecast bias. You build the cross functional interface between sales organization, manufacturing and supply chain to include changes in demand into the supply forecast and 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;
  • Interact with internal teams and sales divisions to understand demand forecast drivers and 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;
  • Provide project management support for the function;
  • Coordinate with Managers in planning and implementing inventory-related changes in production;
  • KPI tracking and improvement (service level, forecast accuracy, etc.);
Key requirements:
  • Bachelor’s degree in Supply Chain Management, Business Management, or related field is preferred;
  • Proven experience as a demand and supply 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;
  • Analytical and logical thinking;
  • Very good numerical and analytical skills (maths and statistics);
  • Detailed oriented with high level of accuracy and problem-solving skills;
  • Effective communication skills;
  • Proficient oral and written skills in German and English;
  • Team player who takes a flexible approach to the role within the team and works effectively with a variety of different groups, employees and managers.
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.

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

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