ALK-Abelló A/S

Senior Design Control Engineer – Design Control and Risk Management

Do you have a proven track record of working with Design Control and Risk Management 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 Design Control Engineer, 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 risk management.

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

  • Design control responsible for drug-device combination products
  • Product risk management responsible of medical device development and life cycle management
  • 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
  • Regulations, standards, and guidelines within the medical device area e.g. ISO 11608, MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30
  • Knowledge and experience with regulatory areas relating to medical device/drug-device combination product development, e.g. cGMP and design controls
  • Experienced within Risk Management processes (EN ISO 14971) and FMEA, including facilitating product risk management activities and creating the risk management file
  • Experience with driving and documenting design control activities such as requirement engineering, design verification and facilitating design reviews

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

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Region:
Region Hovedstaden
Region Sjælland
Job type:
Permanent
Working hours:
Full-time
Working days:
Day
Application deadline:
30/11/2021
Location:
Hørsholm
Company homepage:
http://www.alk.net