Disclaimer

Het alfapump®-systeem is momenteel niet goedgekeurd in de Verenigde Staten of Canada. In de Verenigde Staten en Canada wordt het alfapump®-systeem momenteel klinisch onderzocht (POSEIDON-studie) en wordt het bestudeerd bij volwassen patiënten met refractaire of terugkerende ascites als gevolg van cirrose. Voor meer informatie over de POSEIDON klinische studie zie www.poseidonstudy.com.
De DSR®-therapie is nog in ontwikkeling en er dient te worden opgemerkt dat eventuele verklaringen met betrekking tot veiligheid en efficiëntie voortkomen uit lopende preklinische en klinische onderzoeken die nog moeten worden afgerond.
De DSR®-therapie is momenteel niet goedgekeurd voor klinisch onderzoek in de Verenigde Staten of Canada. Er is geen verband tussen de DSR®-therapie en de lopende onderzoeken met het alfapump®-systeem 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.

Medical Device Engineer Mechanical (Zürich - 100% workload)

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 System;
  • 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.
Required Education / Experience:
  • 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.

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

Apply now

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

Product development Manager Pharma - DSR Infusate (Belgium, Ghent – 80%)

The employee is responsible for coordinating all activities related to Sequana Medical’s proprietary Direct Sodium Removal (DSR) drug product over the full life span of development, manufacturing, and later on maintenance. The role also includes setting up contract manufacturing, clinical and preclinical study supply, and related clinical-regulatory documentation in cooperation with QA/RA. The employee is reporting to the Chief Medical Officer.

Key Responsibilities:
  • Coordinate and take responsibility for design and development of a specific DSR drug product together with internal and external stakeholders and suppliers;
  • Establish and maintain supply chain for clinical and preclinical trials;
  • Oversee and coordinate required Pharma QMS aspects with QA/RA team;
  • Cooperate with the clinical team & management in oversight and execution of clinical study supply according to milestones and deliverables;
  • Maintain project specific documentation and filing;
  • Timely delivery of recurrent tasks with a consistently high degree of accuracy;
Key requirements:
  • Good communication and interpersonal skills;
  • Good understanding of cGMP requirements;
  • Team player with a positive attitude to a swift and flexible environment;
  • Problem solving and hands-on mentality;
  • Good level of English in verbal and writing as this is the Company’s main language;
  • Willingness to travel to stakeholders, providers, and suppliers;
Required Education / Experience:
  • Bachelor or master in pharmacology, life sciences, or related field;
  • At least 2 years’ experience in pharmaceutical product/project management;
  • Experience in clinical research (pharmaceutical products) is a plus;

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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