Device Specification Engineer

Are you passionate about ensuring quality in the manufacturing process? Do you have a knack for creating and managing quality standards and specifications for medical devices? 

If so, you might be our new Device Specification Engineer. Read more and apply today for a life-changing career!
 

 The Position

As a Device Specification Engineer, you will be part of a team of highly skilled engineers that support R&D and our global production network. Your role will focus on ensuring the quality standards for medical device components manufacturing throughout their product life cycle, collaborating across various functional areas to achieve this goal.

The main tasks will be to:

• Establish and update medical device component Quality Specifications throughout the product life cycle.

• Manage and coordinate QFS-related projects for medical device component development.

• Work closely with other engineers to define accurate quality inspection levels for production and defining potential risks and severity levels.

• Support device component production sites with information, clarification and deviation handling.

• Be responsible for Change Request Cases (CR-cases) related to quality specification changes.

Qualifications

To succeed in this role, you have:

• At minimum a bachelor’s degree in bio medical engineering,  mechanical engineering, quality management or similar field.

• Knowledge of FDA regulations: Medical Devices, 21CFRpart820/ QSR, and Drugs and Finished Pharmaceuticals, 21CFRpart211.

• Familiarity with ISO 13485, ISO 11608-1, ISO 2859, ISO 3951, and ISO 14971.

• Experience with Design Control requirements and proficiency in Good Manufacturing Practice (GMP) and Project Management.

• Full professional proficiency in English.

As a person, you are detail-oriented with a strong quality mindset and have an analytical and very systematic approach to work related tasks. Excels in stakeholder management and builds strong, positive relationships.

Having excellent communication skills, interpersonal skills, a collaborative attitude, and the ability to impact others is vital in this role. We will welcome a colleague who has a high degree of flexibility and an open mind as tasks and project priorities change.

About the Department

You will be joining the FPMSAT Component Manufacturing Solutions department in Hillerød, where we have dedicated colleagues specializing in plastic processing, tooling, metal & electronic components, and automation in Finished Product Manufacturing Science & Technology. We develop the equipment and processes that transform new Medical Device designs into actual products for our patients, bridging the gap between the development departments and the Injection Moulding production sites. Our team enjoys sharing knowledge and is eager to learn from new team members. If you appreciate collaboration in a creative and ambitious environment, you will feel at home with us.

About Site Hillerød

Site Hillerød is an innovative and fast-growing production site. With over 4,000 talented employees, we work together to drive change for people living with serious chronic diseases. The site is located in beautiful natural surroundings, and we offer a diverse array of career paths at all educational levels. Join our vibrant community at Site Hillerød and ramp up your career while we ramp up our production! Get to know us better - visit our Site Hillerød career page Novo Nordisk Hillerød.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

For further information, please contact Manager Iranga Perera at irpb@novonordisk.com.

Deadline

20 April 2025.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.