Prototype Engineering Specialist

Are you ready to play a pivotal role in advancing medical innovation and enjoy working at the intersection of engineering, project management, and stakeholder engagement? Are you passionate about leading prototype activities in product development projects enabling the development of quality products that fulfill our customers’ needs?  
  

Then grab this opportunity to join one of the best-performing medical device companies in the world and help make a difference for people with intimate health care needs across the globe.    

“As a Prototype Engineering Specialist, you will be the driving force behind the entire prototype lifecycle in our most ambitious projects. From the very start of a project, you step in as the anchor for all prototype-related activities, guiding the process from initial concept through to the production of samples for clinical trials and design verification. Your involvement is crucial as projects move toward regulatory milestones.” says Majk Kruszewski, Director of Test Engineering.     

A growing team of Engineers  

Joining R&D at our HQ in Humlebæk, Denmark, you become part of a growing team of experts within our Test & Characterization department. We are responsible for testing strategy, test development and the development of prototypes for those activities and more.  

   
“It is an incredibly supportive team, so you will have plenty of opportunity to collaborate with your peers. You’ll connect with passionate experts across engineering, manufacturing, and clinical teams, turning complex requirements into real, testable prototypes. Every day brings new challenges and opportunities to collaborate, problem-solve, and make a tangible impact.” Majk explains.    

From early-stage concepts to final product    
Every project brings unique challenges and being adept at tailoring planning and production processes to fit specific needs, always balancing speed, quality, and compliance. Your impact reduces project risks, accelerates innovation, and ensures that our prototypes are delivered on time and to specification. As a key contributor to our cross-functional teams, helping shape best practices, share knowledge, and drive continuous improvement in how we bring new solutions to life. 
 

Your key tasks include:  

• Act as the one-point-of-contact for all prototype needs in advanced development projects, from kick-off to production for clinical trials and design verification 
• Clarify requirements for prototypes, ensuring they fulfill their intended purpose (e.g. functionality, quality) 
• Ensure traceability and documentation of the prototypes from early prototyping through to production, in alignment with regulatory requirements (CE-mark, FDA clearance) applying Configuration Management traceability as needed based on the intended use of the prototypes 
• Facilitate and coordinate the production of engineering samples, pre-production, and ad-hoc prototypes, tailoring processes to project needs 
• Maintain systems for full transparency of prototype needs and status for all project stakeholders 
• Manage stakeholder complexity, including internal/external partners, multiple manufacturing sites, and equipment validation 

It is vital that you thrive in a project-based environment. You know how to navigate a diverse stakeholder landscape and coordinate and facilitate tasks that span multi-disciplinary technical disciplines.  
   

Moreover, you:  

• Hold a degree in Engineering or equivalent 
• Strong project management and stakeholder engagement skills 
• Strong passion for prototype planning, production, or engineering within a regulated R&D environment 
• Deep curiosity and commitment to understand manufacturing processes, configuration management, and documentation requirements 
• Ability to manage complexity, prioritize tasks, and communicate effectively across functions 
• Proactive, disciplined, and holistic thinker with a hands-on approach 
• Familiarity with regulatory requirements for medical device development 

 
Interested?   

If you would like to know more about the position, please contact Director of Test Engineering Mikael Kruszewski at dkmkru@coloplast.com.  

We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate is found.  

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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