Senior Medical Device Scientist –Usability Engineering and Design Control

Would you like to be working with Usability Engineering and Design Control for medical device development and life cycle management? Are you perceived as a structured and constructive person with excellent collaboration skills? Would you like to contribute to the quality of life for people with allergy?

You might then be the colleague we are looking for.

As Senior Medical Devices Scientist, you will be joining a team of medical device engineers and scientists working in the cross-field between device development, production transfer and technical support to the production site. The position requires extensive experience with development of medical devices with focus on design control and usability engineering.

Our team, Device Development and Support, consists of dedicated colleagues with a high team-spirit and competencies within mechanical design, medical device development, design control and risk management, and clinical evaluation of drug delivery products. The position is located in Hørsholm.

Fields of responsibility

• Human Factors and Usability engineering for medical device products
• Design control for drug-device combination products
• Writing, reviewing, and updating product requirements (Design Control)
• Execution of change control, deviation handling and CAPAs

Your qualifications

• M.Sc. degree or similar within medical devices, mechanical engineering, or equivalent educational background
• Minimum 7-10 years of experience – preferably within Medical Device - Drug Combination products
• Understanding of industry regulations as it pertains to medical devices, external standards, design controls, quality controls, and manufacturing methods
• Knowledge on interpreting international standards such as EN ISO 13485, FDA 21 CFR 820.30, EN ISO 14971 and ISO 11608
• Experience with FDA requirements for Human Factors and Usability Engineering
• Knowledge and experience with regulatory areas relating to medical device/drug-device combination product development, e.g. cGMP and design controls

In addition, we expect you to

• Have a structural approach to problem-solving and documentation
• Be a hands-on person
• Have a pioneer spirit – we are building new function in ALK
• Be a team player – you must show flexibility and we help each other
• Have interpersonal skills; strong and proven relationship building skills/cross-cultural skills
• Be able to work independently on broad tasks and minimal supervision
• Speak and write English fluently

We offer

ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.

Application deadline

30 November 2021

Contact

For further information on the position, please contact Rolf Singer, Senior Director, Device Development & Support. +45 61911038, rsndk@alk.net