About the Design & Development Specialist Role

The Product Development department at Ferrosan Medical Devices is comprised of 16 dedicated professionals organized into three specialist teams: The Design & Development team, The Biosafety & Labelling team, and Product Owners.

As a Design & Development Specialist, your primary focus will be on development projects. The project portfolio is diverse and includes new product development, line extension, optimization (both Process and Product), and capacity expansion projects.

In these projects, you will play a pivotal role in Design Control, setting technical requirements, managing design input and output, verification, and validation. You’ll be responsible for compiling technical evidence to meet Medical Device Class II and III requirements. All solutions must be meticulously documented and described in alignment with Design Control and/or GDP standards. Collaborating extensively and managing stakeholders across the organization is crucial for success.

Your Role

Within project teams, your role may vary depending on the size and complexity of the project. You might take on one, two, or all three of the following roles:

  1. Design Control Coordinator
  2. Design Risk Manager
  3. Design Verification Specialist

Regardless of your specific role, you will always act as a team player, fostering an open-minded approach and actively seeking solutions alongside your teammates.

Your responsibilities will include:

  • Defining Design Requirements and managing Design Inputs and Outputs
  • Performing Design Verification
  • Conducting Design Reviews and Design Transfer
  • Managing traceability and maintaining a coherent storyline across technical documentation
  • Overseeing product risk management, including creating the Hazard Traceability Matrix
  • Engaging in Project Planning activities and taking responsibility for tracking project status within Design Control

Qualifications

To excel in this role, you should possess the following qualifications:

  • A background in the Medical Device Industry, potentially in conjunction with pharmaceuticals
  • Experience in areas such as Research and Development, Regulatory Affairs, or Quality Assurance, with a primary focus on new product development
  • An academic background with a master’s degree in life sciences (human biology, pharmacy, chemistry, engineering, or similar)
  • Previous experience with Design Control
  • A keen attention to detail
  • A “can-do” attitude and the ability to thrive in a dynamic environment
  • Strong interpersonal skills and a knack for collaborating with a multitude of stakeholders
  • The ability to contextualize your work in a cross-functional reference
  • Proficient oral and written communication skills in English

What’s Offered

Ferrosan Medical Devices offers a purpose-driven workplace with deep-rooted values. This commitment to values is evident from day one, as the organization prioritizes improving patient outcomes and upholds values such as care, environmental responsibility, and customer focus. The company wins with innovative, high-quality solutions.

This inclusive workplace provides you with the opportunity to make a tangible impact and chart your own development path at your own pace. You’ll be part of a Danish-rooted company that’s rapidly expanding its international presence. The way of working embraces hybrid models, digital tools, learning, and innovation. And, importantly, the team takes pride in having fun together!

About Ferrosan Medical Devices

Ferrosan Medical Devices is dedicated to developing and producing a portfolio of medical devices used in surgical care. The portfolio includes various hemostatic products designed to minimize bleeding challenges in surgery and electromechanical medical devices used for breast biopsies. The company is international with products registered in more than 100 countries. Collaboration with global medtech partners markets the products. The approach nurtures new ideas from inception to production, all while maintaining an unwavering commitment to quality in accordance with current GMP requirements.

Ready to Join

If you’re eager to join a dynamic and innovative team in the healthcare industry, submit your application along with your CV today. Applications are processed as soon as they are received.