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R&D Process Development Engineer – with focus on Statistical Analysis

Cook Medical is forming a new department in the global Research & Development space with the purpose of facilitating the development of manufacturing processes and equipment. The department will work closely with the R&D departments and the Manufacturing Department to ensure quality and progress in the “Transfer to manufacturing” for R&D projects. The department will consist of 8 employees, where we are looking for Engineers with experience in development of production processes and process equipment.

The position will give you an attractive opportunity to make sure we have sufficient data to make data-driven decisions - thereby securing robust manufacturing processes. The goal is also to make sure we have the right data to select the right materials for existing and new processes and products, to ensure optimal manufacturability in an innovative global medical device environment.


You will be responsible for the development of production processes and production equipment for Research & Development projects.

Your tasks will be to:

  • Ensure data-driven decisions, when identifying new production processes and improving existing processes.
  • Carry out DoE and identify process windows and critical process parameters.
  • Identify and specify input to relevant production processes in relation to R&D development projects.
  • Give inputs to optimization and streamlining of processes on existing products and production equipment.
  • Lead projects in the department and report the progress of the projects to relevant stakeholders.
  • Identify and give early inputs to relevant test methods for Validation and Quality monitoring.
  • Participate in R&D projects and give input to DFMA and production setup.
  • Carry out Risk Assessment pFEMA and give input to Risk Mitigation Plan.
  • Assist in performing process validations as well as introducing machines, equipment and processes in production.
  • Travel activities must be expected to some extent.


  • Technical education, preferably mechanical or process engineer with preferred minimum 4 years of experience within R&D process development in the medico industry.
  • Experienced in project management and stakeholder communication in an R&D environment.
  • You should be fluent in both Danish and English.
  • Minimum Green Belt in Six Sigma.

Furthermore, the profile we are looking for should have the following personal qualifications: 

  • Be able to work across the organization, both independently and in teams - in an international environment.
  • Be flexible, have good communication skills and have a good technical understanding.
  • Structured approach to problem-solving and able to keep the overview also in stressed situations.

We offer

Cook Medical has a healthy company culture with a strong common set of values. Responsible, competent and professional staff is our most important resource. We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty and humour are highly appreciated.

The staff of Cook Medical helps to uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - we make a difference every day.

Cook Medical offers a well-organized internal training course which is taken by all new staff to enable them to quickly gain thorough knowledge of the company.

In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, as well as free use of the company’s own gym.

Further information

For further information about the job, please feel free to contact Jan_erik Enoch Rasmussen, Manager, R&D Process Development on phone +45 20687788  or by e-mail

Deadline for applications is December 11,  2018.

Closed for applications Gem job



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