Prototype Engineering Specialist

Prototype Engineering Specialist

Coloplast

Humlebæk, Denmark

Your key tasks include:

• Act as the one-point-of-contact for all prototype needs in the more 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;
• Establish and 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;
• Experience in prototype planning, production, or engineering within a regulated R&D environment;
• Good understanding of 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.