The employee is responsible for supporting and coordinating all activities related to Sequana Medical’s proprietary Direct Sodium Removal (DSR) Infusate over the full life span of development, manufacturing, and later on maintenance, including support in 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 Infusate 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;
• Support 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 life sciences or related field;
• At least 2 years’ experience in pharmaceutical product/project managing;
• Experience in clinical research (pharmaceutical products);

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

Apply now

The HR Manager is supporting and advising line managers spread over several European countries and acting as a point of contact for employees with the aim of providing optimal support in the development and execution of the HR policies and processes. The HR Manager provides daily support to management and answering questions from employees to continue to build a high-performance organization. Furthermore, the HR Manager brings organizational and administrative support within one or more HR Domains.

Key Responsibilities:

• Actively participate in the various HR projects that are set up and rolled out and participate in the continuous evaluation and optimization of the various practices in order to contribute to a maximum HR efficiency;
• Implementing and communicating HR policies and HR processes within the organization, taking into account the global and local policies and/or legislation and acting as a contact point for questions related to this, with the aim of ensuring proper compliance with the global HR policy and making adjustments where necessary;
• Supporting the human resources administration and advising on personnel matters in the broad sense (payroll processing, social legislation, internal agreements, HR-related insurance, training, pension, stock option plans, etc.) with the aim of ensuring that employees and/or line managers have correct information at their disposal;
• Acting as an internal HR specialist and formulating advice and recommendations on HR-related issues in order to encourage line management to conduct an HR policy in accordance with Sequana Medical’s regulations and HR policy;
• Maintaining personnel data in the personnel management systems with the aim of having correct and complete information respecting the Standard Operating Procedures;
• Responsible for the coordination and follow up of the annually performance review process;
• Establishing HR departmental measurements that support the accomplishment of the company’s strategic goals;
• Supervising and following up the entire recruitment and selection process (from job description up to onboarding) with the aim of placing the right employee in the right place and being able to work with an optimally balanced staff;
• Keeping him/herself continuously informed about evolutions on developments in the field of HR and keep his/her knowledge up to date in function of evolutions with the aim of strengthening his/her credibility by offering a service that is continuously based on updated knowledge;
• Participating in organizing trainings;

Key requirements:

• Good communication, negotiation and interpersonal skills;
• Team player;
• Problem solving and hands-on mentality;
• Detailed work ethics;
• Positive attitude to a swift and flexible environment;
• Act with discretion, integrity and professionalism;
• Good level of English in verbal and writing as this is the Company’s main language;
• Willingness to travel regularly to Zürich;

Required Education / Experience:

• Master;
• At least 5 year experience;
• Good knowledge of social legislation;
• Experience in an international work environment;
• MS Office (Excel, Word, Powerpoint);

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

Apply now

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

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

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

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

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