Process Engineer

Job Description
CeQur ApS is located in Nordborg, Denmark and Marlborough, US. The company is focused on development and commercialization of simple insulin delivery devices. We are a team of entrepreneurially minded engineers, and scientists, working in close collaboration to bring our insulin device from a prototype phase into a full scale consumer product that will improve everyday lives of diabetes patients.

CeQur ApS is now looking for an engineer to be part of the manufacturing team in Denmark focusing on manufacturing one key product component, a micro capillary with high precision flow resistance. Capillary manufacturing is currently based on our pilot manufacturing plant and in parallel with this new automatic equipment has to be developed and take manufacturing capability to a new level for full scale-up. The candidate will be a process engineer with background within manufacturing of high precision parts meeting the high quality standards for medical devices used for drug delivery.  This position will be based in Nordborg requiring minor travel to Marlborough, USA. 

Responsibilities

• Be part of the team responsible for the manufacturing of the micro flow restrictors.
• Provide inputs for specification of hardware and software for the new generation of automated production equipment. 
• Develop, design and test the future automated chemical etching process and make it capable of mass production.
• Lead the development of automatic production equipment in cooperation with external suppliers.
• Document manufacturing processes and equipment to a medical device Quality System.
• Support and execute process validation of manufacturing processes (IQ, OQ, PQ).
• As we launch mass production support production and continues improvements.

 Qualifications

• B.S. or M.S. degree in production or chemical engineering (or similar educational background and key past experience) required.
• Approximately 3 years of relevant job experience. Medical device experience is a plus.
• Good understanding of advanced automation equipment for high precision parts in micro scale. 
• Experience developing and maintaining process with the use of industry methods such as FMEA, GRR, Process Capability Studies (Cpk, Ppk), Control Plans.
• Skills for collecting and setting up production data for statistical evaluation of the manufacturing processes with use of SPC and Six Sigma tools.
• Experience and knowledge in manufacturing products under ISO 13485, GAMP5, MDD, and FDA/GMP procedures is a plus.
• Have personal drive and the ability to motivate others by your own example, showing trust, coaching and a good sense of humor.
• A team-oriented player who collaborates and communicates effectively with local and international team members in a cross-functional, multi-cultural, interdisciplinary environment.
• Fluent in English language both spoken and written.

Contact:     
Manufacturing Manager - Nicki Lundstrøm Holm - nlh@cequr.net -
+45 2277 3494 or Office Manager - Bettina Kryhlmand Collin - bkc@cequr.net - +45 7488 1631

Apply via "Ansøg" button.

Please write in your application that you've seen the job at Jobfinder