R&D Engineer for Process Development

Overview We develop and ensure the quality of medical equipment for treating patients with critical vascular diseases worldwide. Would you like to join us?Then become part of Cook Medical’s development department and take on a role in the Danish development projects while building a vast network in a global organization. Here, you will join a team passionate about process development and production improvement in developing new products.You will be part of our Process Development team with 6 colleagues. We all work across R&D in Denmark and are involved in development projects with a focus on process development. Therefore, you will have a daily work routine where you are part of a highly skilled unit, and you will also collaborate, brainstorm, and develop with Engineers, Project Managers, and Technicians in specific project team. Responsibilities As an R&D Engineer in Process Development, your primary responsibilities include:Integrate production processes early in the development phase: Ensure that production processes are considered from the beginning of development projects.DFMA (Design for Manufacturing and Assembly): Implement DFMA principles to optimize the production and assembly of new products.Specification and qualification of equipment: Develop specifications and qualify production equipment for new products.Process risk analysis: Conduct risk analyses of production processes to identify and mitigate potential issues.Understanding process characteristics: Analyze and understand process characteristics to improve and optimize production processes.Development of test methods: Design and develop test methods to ensure product quality and performance.Control of FAT/SAT activities: Oversee Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities to ensure equipment meets required standards.Collaboration with Manufacturing Engineering: Work closely with Manufacturing Engineering to ensure the transfer of robust processes to production.Project Management: Take responsibility and ownership of large sub-tasks and ensure their successful completion. Qualifications We are looking for a new colleague who:Has strong process validation, test method validation, and equipment qualification experiencePossesses statistical knowledge, beneficial for DOE (Design of Experiments) and process validation tasks.Might already have knowledge of the medical device industry or other regulated industriesIs patient and persistent, thriving in projects with long timelines and industry-specific requirements.Is proud of their work but also pragmatic, and able to collaborate in a team with diverse expertise.Is fluent in Danish and English, both written and oral.Is a true team player.Cook – a special workplaceCook Medical is a family owned, American company with well over 12.000 employees worldwideWe invent, manufacture and deliver unique medical devices to the health care systems of the world. Serving patients is a privilege and we demand the highest standards of quality, ethics, and service in all that we do.In Denmark, we are approximately 800 colleagues based in Bjaeverskov and Ringsted, respectively.At Cook Medical, we are proud of our special ”Cook spirit”. All over the organization, you are met with courtesy and pride of the quality of the work we carry out and the devices we develop. As a Cook employee, you contribute to the development of innovative, unique medical devices – and we are aware that we make a difference to patients all over the world every day.We appreciate qualities such as decisiveness, loyalty, and humor and work for an open dialog.As a new Cook colleague, you are offered a well-organized internal training course enabling you to quickly gain a thorough knowledge of the company. Apart from a salary package comprising bonus and pension schemes, we offer a high degree of flexibility in the planning of your daily work with the assignments in focus, equipment for teleworking, a good canteen when you are onsite, health assurance, and activities such as an Arts’ Society, a Sports’ Society and free use of the company’s own fitness center.Interested?If you see yourself in this role, please send us your CV including a short motivation via the link below at the earliest convenience and no later than Sunday, October 27th 2024.If you have any questions about the job, please contact Team Lead for Process Development, R&D, Rejan Gashi at +45 28 77 48 02.We look forward to hearing from you!