Senior Design Control Engineer, Design Control and Risk Management, ALK / 1873

The Company
ALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple they make a difference for many people. The Company builds upon a strong heritage as a pioneer in allergy immunotherapy and they will continue to innovate, develop, and market new products and solutions for people with allergy. ALK is a global company with production sites in Denmark, France, Spain, and the United States. They were founded in Copenhagen in 1923 and today ALK employ around 2,900 people around the globe. Headquarter is based in Hørsholm north of Copenhagen. ALK knows that their employees are their most valuable asset, and they believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join them on their exciting journey.

The Team
Device Development and Support consists of a small team of engaged colleagues and you will be playing a key role in planning and executing the design-controlled documentation to support the development pipeline within drug device-combination-product and commercial success. This also includes risk management, ranging from planning and execution on risk management activities and deliverables. The team 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.

Senior Design Control Engineer
Design Control and Risk Management

• Making a real difference in people’s lives within allergy
• Responsible for medical device development and life cycle management
• Help developing a Life Saving Device from idea to production

The Challenge
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.

The position is an opportunity to contribute to the development and documentation aspects of the Life Saving Device, a drug device-combination-product. You are responsible for the risk management activities, as they move from project initiation through development and testing, manufacturing, global submission, and commercialization.

All tasks will be carried out in close collaboration with other functions (RA, QA, Project Leaders etc.) and thus it is of importance, that you thrive by working in a cross functional environment and has a good understanding of the device and drug development processes.

Your main responsibilities will be:

• Design control responsible for drug device-combination-product
• 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

Would you like to join ALK in this challenging position? The company 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. The flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making. You will be part of an engaged and informal team, who values skill and knowledge creation. ALK consider their pioneering spirit coupled with their trustworthiness to be their winning formula. ALK is a health focused organization, and their offices offer a green view of the DTU Science Park in Hørsholm. You will report to the Senior Director, Device Development & Support (DDS).

Your Talent
You have a M.Sc. degree or similar within medical devices, mechanical engineering or equivalent educational background and a minimum of 7-10 years of experience – preferably within medical device – drug-combination products. You understand the industry regulations as it pertains to medical devices, external standards, design controls, quality controls, and manufacturing methods.

In addition, we expect you to:

• Work with regulations, standards, and guidelines within the medical device area e.g., ISO 11608, MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30
• Have knowledge and experience with regulatory areas relating to medical device/drug-device combination product development, e.g., cGMP and design controls
• Have experienced within Risk Management processes (EN ISO 14971) and FMEA, including facilitating product risk management activities and creating the risk management file
• Have experience with driving and documenting design control activities such as requirement engineering, design verification and facilitating design reviews

As a person, you have a structural approach to problem-solving and documentation. You are motivated by facilitating new ideas and ways to work, by finding the essential elements in an often unpredicted development phase and you have a keen interest in drug delivery devices including the design control aspects. You are a hands-on person and have a pioneer spirit.

You are a strong communicator of ideas, direction and solutions and are able to navigate in an environment with many stakeholders. You have a proven record of accomplishment for successful design control and risk management execution. Fluency in English with good verbal and written language skills is a given.

Application
Best Talent is responsible for the recruitment process for this position at ALK and review your application on a confidential basis. Forward your application including your CV attention ”1873/Design Control” by way of e-mail to [email protected]. You can read more about Best Talent at www.besttalent.dk.