R&D Process Development Engineer of Medical Devices
Do you want to be a part of a team developing raw balloons for the treatment of patients with blood vessel diseases? We are looking for an engineer with experience in development and validation of R&D processes.
The Raw Balloons Development is one of Cook Medical's R&D departments and is responsible from the development of the raw balloon components including transfer to manufacturing of the design and process on site.
You will be responsible for the development of the R&D processes in the Raw Balloons Development and the process validation ensuring quality and progress. You will be working closely with colleagues onsite as well as in the US both from our Manufacturing Facility and our supplier of the raw materials.
The position will give you an attractive opportunity to ensure the basis for data-driven decisions thereby securing robust manufacturing processes for mass production and a solid component design. The goal is also to make sure we have the right data to select the right material and processes for new products to ensure optimal manufacturability.
Your tasks will be to:
- Identify and specify inputs to relevant production processes in relation to balloon development projects.
- Optimize and streamline new and existing processes.
- Assist with specifying balloon raw material and production equipment.
- Carry out Risk Assessment pFMEA and give input to Risk Mitigation Plan and dFMEA.
- Execute DoE statistical analysis for the identification of process windows and critical process parameters.
- Plan and execute process validations.
- Identify and give early specification input to relevant test methods for validation and quality monitoring.
- Engineering degree with experience within the Medico Industry.
- Substantial experience with polymer material or relevant educational background related to this type of material.
- Experienced in Project Management in an R&D environment.
- Preferably Green Belt in Six Sigma.
- You should be fluent in both Danish and English.
- Experience in balloon forming process or extrusion is desirable, but not required.
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 strong technical understanding.
- Structured approach to problem solving and able to maintain the overview when the going gets tough.
- You keep an open mind and have a good sense of humor.
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.
For further information about the job, please feel free to contact Bente Weber, Manager Raw Balloons Development on phone + 45 56 86 86 20 or by e-mail firstname.lastname@example.org.
Deadline for applications is August 16th, 2019.