Under the Direction of the Chief Medical Officer, the Director of Clinical Operations will be leading the execution of our current and future clinical trials assigned to the director, which includes the management of the clinical department in collaboration with the other management functions in the clinical department.

Key Responsibilities:

As a key member of the company’s management team, lead the company’s Clinical Department in collaboration with other management positions in the clinical department and be responsible for the successful execution the company’s clinical trials and clinical trial strategy assigned to the clinical director.

Design and set-up new clinical studies and manage their timely execution, including the execution of ongoing studies, up to completion, including finalization of clinical study reports and publication. You will work with the Company’s established research partners and you will help establish new research partners.
Principal duties associated with these responsibilities are summarized as follows:

1. Provide leadership and management direction to the clinical and safety team members for the assigned programs, this includes oversight for the following activities listed, but not limited to:
   • International pharma and device study protocol development and implementation, CFR Design, project planning and report writing;
   • Lead / assistance with site selection and investigator recruitment;
   • Assisting sites with EC applications;
   • Site initiation and staff training (including CRO training);
   • Monitoring of clinical data;
   • Study drug and device inventory and reporting;
   • Adverse event monitoring and reporting;
2. Represent, together with other clinical management team members, the clinical team and ensure clinical requirements are aligned with other internal departments (such as, but not limited to R&D, Drug Procurement, Regulatory and Quality, Human Resources)
3. For the assigned projects ensures the clinical requirements for regulatory filings are met (Notified Bodies, including Post Market Clinical Follow up, FDA, EMA, and other where applicable)
4. Collaborate with in- and external partners (including investigators) to drive study results presentation and/or publication
5. Oversee and coordinate CMC / infusate supply activities in cooperation with other Clinical or Supply Chain team members
6. Set and maintain assigned clinical operations budget for assigned programs
7. Oversee- for assigned programs – clinical study execution to ensure studies are completed on time, within budget, and in compliance with Pharma and Device SOPs, ICH/GCP/GxP guidelines, and applicable regulations
8. Mentor and develop clinical team members to foster individual growth and promote internal talent
9. Develop training plans and programs to enhance clinical operations

Key requirements:

• Demonstrated capacity to lead a clinical team, including remote employ;
• Ability to develop and maintain professional relationships with hospitals, doctors and clinical staff;
• Strong interpersonal and communication skills, including the ability to present results at major scientific meetings;
• Expert knowledge of how to conduct a GCP study and experience with regulatory requirement for Pharma and/or Medical Device clinical studies (including IND/IDE, PMA, CE-mark / MDR);
• Good organizational and project management skills and ability to handle multiple diverse projects simultaneously;
• Experience developing and executing a scientific publication strategy, as well as organizing small scientific meetings (such as expert meetings or advisory boards);
• Ability to conduct interviews with physicians to gain feedback on products;
• Expert proficiency in reading, writing and speaking English;
• Ability and appetite to work in a fast paced start up environment;
• Desire to help develop strategy marketing plans;
• Interest in working with R&D to ensure that new products exceed customer expectations;
• Position may require up to 50% travel;
• Work 50% in Ghent office / 50% at home (Company Policy).

Required Education / Experience:

• Post graduate Degree in Life Sciences or appropriate experience;
• 7+ years of Pharma and/or Medical Device Clinical Trial Management (ideally experienced within Active Implantable Devices and/or Pharmaceutical Infusion Products in an international context);
• Good knowledge of CMC processes / pharmaceutical manufacturing is a plus;
• Proficient in reading, writing and speaking English (multiple languages is a plus);
• Knowledge of and expertise in (ideally including a KOL network) the following therapeutic domains are considered a strong advantage: heart failure and/or chronic liver disease.

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

Apply now

The manufacturing engineer’s responsibilities include introduction of new products, designing of new processes, identifying areas for improvement, maintaining high levels of manufacturing and product quality as well as ensuring cost-efficiency and conformance with regulatory standards.
Furthermore, a Manufacturing Engineer is responsible for designing, implementing and reviewing the procedures and equipment involved in the manufacturing process. Their duties include researching automation techniques, testing new systems for efficiency and planning factory layouts to optimize production.
To be successful as a manufacturing engineer you should be able to work effectively within a team and have a high level of technical expertise.

Key Responsibilities:

• Lead or support internal projects.;
• Initiate and manage change management activities (CR/CO);
• Support the implementation of new products in our current production lines.;
• Support the definition of new process flows for existing or new products;
• Support the design transfer of products to internal production or suppliers;
• Lead or support CAPAs, NCMRs and Process deviations;
• Define and develop manufacturing processes, equipment, tools, fixtures, and methods;
• Create or support the creation of URS for new assets;
• Contribute to the elaboration of business cases;
• Define, create, review and update manufacturing documentation;
• Manage in ERP/MRP product and process information;
• Support validation activities like: validation assessments/validation plans, FAT&SAT protocols, IQ, OQ, PQ protocols and reports, CSV compliance analysis, test method validation, final inspection reports;
• Create, store and maintain information/documents in the QMS system;
• Interface with our suppliers, other Sequana sites and internal stakeholders on technical and organization issues;
• Actively seek opportunities for process improvement;
• Cultivates and upholds a culture of interest and participation and demonstrates a collaborative approach to working with others;
• Incorporates and respects cGMP concepts (Good Manufacturing Practices);
• Accountable to the execution on time and in the required quality of the requested activities;
• Maintain a structured and reliable activities scheduling (workload).

Key Requirements:

• Strong knowledge, interest and experience in electronics and mechanical manufacturing operations;
• Experience in medical implants manufacturing;
• Excellent problem solving and manufacturing process improvements skills (Six Sigma, Fishbone, 5-S, 5-Whys, 6M, …);
• Ability to think and act cross-functionally, interacting with various SMEs (Shop floor, QA, QC, engineering, etc.);
• Ability to effectively present information and support all stakeholders;
• Autonomous, structured, self-motivated, flexible, resilient with proactive and analytical thinking;
• Able to manage priorities in a fast and dynamic environment with a high emphasis on achieving results;
• Demonstrate excellent communication skills orally and written, ability to describe complex technical processes and qualifications and to translate it into clear, precise reports;
• Knowledge of automation technology is big plus;
• Excellent oral and written skills in German and English, fluency is an asset.

Required Education / Experience:

• 3+ years of experience as a Manufacturing or Process Engineer;
• Ideally with experience in medical, pharma or food environment (ISO 13’485, FDA);
• Knowledge of ERP systems, QMS systems, Solid Works (CAD) is a plus;
• Ideally demonstrated experience in application of Six Sigma and Lean Methods;
• Proficiency with personal computers, office applications and technical software.

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

Apply now

Are you someone who loves to work in a fast paced, challenging environment where you will have the opportunity take on an impactful role in defining and driving purchasing initiatives? Do you thrive working in an environment where you can utilize your procurement skills to solve problems and build long-term solutions to advance procurement initiatives? Do you pride yourself on having an entrepreneurial spirit with the ability to see the big picture, deliver solutions and streamline processes? If you answered yes, we would love to discuss our Technical Buyer opportunity with you!
In this role, you will play an integral part in defining and modeling the future of procurement directly associated with Sequana Medical’s production.

Key Responsibilities:

• Ensure continuous supply of required goods and materials and communicate any supply problems which may pose a risk or impact on business operations;
• Ensure reliable performance for on-time, complete, and accurate delivery with the best value meeting requirements at the lowest cost;
• Stay current and up to date on any changes that may affect the supply and demand of needed products and materials and advise others of any impact;
• Support product change requests, review and communicate the impact on operational activity and capacity plans;
• Monitor and report on component obsolescence and develop plans for improving component obsolescence management;
• Support implementation and management of on-going operations for Procurement and eProcurement solutions;
• Support operations for the purchasing process primarily requisitioning and ordering;
• Process POs; ensure all necessary approvals are documented, the orders are placed, and shipments delivered on time;
• Work with the cross-departmental team(s) and suppliers to get feasibility studies and quotes on new items. Review and select best quotes from time, quality and pricing standpoint;
• Work collaboratively, negotiate and engage with stakeholders and suppliers regarding new projects, supplies, initiatives and advise on impact of change on purchasing and production activities;
• Contact suppliers to resolve price, quality, delivery or invoice issues.

Key Requirements:

• Proven purchasing experience and knowledge of relevant purchasing and sourcing concepts, preferably within the electronics manufacturing environment;
• Strong technical knowledge and understanding of electronics manufacturing processes;
• Project management experience;
• 3+ years’ experience in purchasing environment;
• Medical device background and knowledge of relevant regulations (ISO 13485, FDA 21 CFR 820, etc.) quality systems and relevant concepts is an advantage;
• Resilient, self-motivated and able to work well under pressure;
• Proficiency in MS Office products, ERP systems and its underlying business processes;
• Fluent in verbal and written English and German.

Required education and professional experience:

• Bachelor’s degree (B.A.) in a relevant business/commercial or manufacturing/engineering degree or equivalent education;
• Technical background and an apprenticeship in relevant field is an asset;
• Relationship/team builder, both internally and externally with suppliers and employees;
• Exhibits a high degree of ethics and integrity with full transparency and builds trust;
• Ability to coordinate several projects simultaneously;
• Analytical, numerically astute with strong proven problem identification and solution abilities;
• Attention to detail and accuracy;
• Engages interest and participation of others and has a collaborative approach to working with others;
• Proactively contributes to the team, optimistic and open to change;
• Computer literate, to include advanced Excel skills;
• Very quality oriented, organized and reliable.

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