Material Engineer for the Medical Device Industry

Job title:

Material Engineer for the Medical Device Industry

Company:

Cook Medical

Job description

OverviewDo you want to help ensure the biological safety and chemical compliance of medical devices for treatment of patients suffering from blood vessel diseases worldwide?
And are you experienced in evaluation of materials used in medical devices and motivated by ensuring that the materials used in our lifesaving devices consists of safe and compliant materials?If so you might be a good match as part of our Material Team in the Post Market Engineering Department.ResponsibilitiesThe Material team is responsible for the compositional information and chemical compliance of the raw material used in our devices. We collect and evaluate information on raw materials provided by suppliers and ensure that the information provided to regulatory bodies are correct and in compliance with the relevant regulations, including the EU-MDR and REACH.The Material team consists of 11 specialists and engineers working on raw materials, biocompatibility and non-conformances. Daily knowledge sharing is very important for our collaboration and work, and we always enjoy a good laugh while working professionally. Our team has a high degree of professionalism with various academical and engineering backgrounds. This means that we complement each other’s knowledge of materials, engineering and biology. The job offers a high degree of flexibility with the possibility of working partly from home.Your primary working tasks will be:

• Maintain an excellent understanding of the global medical device regulations especially with respect to material regulations for example EU-MDR and REACH.
• Subject Matter Expert (SME) for WCE’s material processes and ensure maintenance of relevant Quality Management System documents including preparation of gap-analyses
• Collaborate with other Cook sites on the global material database
• Collect and evaluate information on materials and processing aids from suppliers to ensure regulatory compliance for our devices
• Evaluate and prepare documentation for materials of construction
• Reply to material related questions related to external partners
• Prepare EU-MDR and REACH compliance documentation reports

QualificationsBackground and experience

• You hold a bachelor or master degree in chemistry, chemical engineer, or equivalent
• You have experience with working with materials for medical devices
• You have experience within medical device regulation and/or REACH regulation
• You have a systematic approach to your assignments and a flair for document handling and control
• You have excellent communication skills
• You are able to work both independently and, in a team
• Proficiency in Danish and English both verbally and in writing is a prerequisite. English is our corporate language,

Cook as a workplaceCook Medical is a family owned, American company with well over 10.000 employees worldwide.
We invent, manufacture, and deliver unique medical devices to health care systems across the world. We believe that serving patients is a privilege and we demand the highest standards of quality, ethics, and service in everything we do.
In Denmark (WCE), we are approximately 700 colleagues at two sites in Bjæverskov and Ringsted, respectively.At Cook Medical, we are proud of our special “Cook spirit”. Across the organization, you will be 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 – we make a difference to patients all over the world on a daily basis. We value qualities such as decisiveness, loyalty, and humor practiced in an open and friendly atmosphere. As a new Cook colleague, you are offered a well-organized internal onboarding program in order to get familiar with our company structure and your work assignments. Apart from a salary package comprising bonus and pension schemes, we offer a high degree of flexibility in planning of your daily work, and a standard package of equipment to set up your home office, favorable onsite canteen facilities, private health insurance, as well as a selection of voluntary activities and memberships including art association, sports association and free use of the company’s fitness center.Does this look like a good match?If you recognize yourself in this role, please send your application and summary via the below link at the earliest convenience and no later than April 7th 2025. We invite candidates into the recruitment process continuously and fill the position once we have found the right match.If you have any questions related to the job, please feel free to reach out to Thit Juul Fink Mørck, Manager Post Market Supplier Engineering on Thit.Moeeerk@ookMedical.com or +45 56868390 (direct).For further information, please visit www.cookmedical.comWe look forward to hearing from you!

Expected salary

Location

Bjæverskov, Sjælland

Job date

Sun, 16 Mar 2025 01:07:48 GMT

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