Design & Development Specialist

at  Ferrosan Medical Devices

DESIGN & DEVELOPMENT SPECIALIST – REQUIREMENT ENGINEERING

Do you want to be a part of Product Development in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.
Every 2nd second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!

REQUIREMENTS ENGINEERING & DESIGN CONTROL

If you’re passionate about requirement engineering and design control in the field of medical devices and combination products, and you aspire to make a significant impact on global healthcare and patient outcomes, Ferrosan Medical Devices offers an exceptional opportunity to be a part of our Product Development department, a team with a unique role in enhancing surgical care.
You will be a part of the Product Development department, which consists of 23 employees organized into 3 specialist teams: The Design & Development team (11), The Biosafety & Labelling team (9), and the Product Owner team (3).
Your primary focus will be on product safety, performance, and functionality of our products (Class II and III medical devices incl. combination products). You will play a crucial role within project teams and in ongoing operations. Your role will primarily be as Design Control Coordinator but can also be Design Risk Manager or a Design Verification Specialist, depending on the scope and complexity of the project. A considerable part of your role will involve setting product requirements, which requires a collaborative spirit and a flexible approach. Be prepared to engage in problem-solving beyond your designated role to support the team’s objectives.

YOUR ROLE

Upon your start, you will be assigned to a late-stage project, where you will be responsible for ensuring that all technical documentation used for filing is in order. This will include tasks such as aligning all documentation, ensuring all rationales are in place, and writing them if necessary. You will also be asked to take a lead role in finalizing design transfers.

Key responsibilities in your role include:

• Design Control Coordination:
• Manage the Design and Development Plan and Change Requests, ensuring integration with QMS.
• Oversee technical documentation and processes to maintain project clarity.
• Ensure compliance with regulatory standards and quality management systems.
• Develop and maintain design history files (DHF).
• Conduct design reviews and facilitate the design transfer process.
• Product Development and Requirement Management:
• Identify, develop, and manage product requirements aligned with stakeholder needs and product goals.
• Facilitate the creation of product architecture and key design decisions, documenting rationalizations and specifications.
• Review design verification activities to confirm design requirements.
• Ensure traceability between requirements, device design, and verification activities.
• Ensure product requirements are met throughout development.
• Strategic Oversight:
• Maintain a high-level overview to anticipate potential risks and opportunities.
• Lead project planning and monitor project progress within the framework of Design Control.
• Documentation Improvement:
• Enhance documentation for clarity, compliance, and efficiency, reflecting updates throughout the product lifecycle.

About you
You have a robust background in medical devices, possibly combined with pharmaceutical experience. Your career has encompassed roles in Research & Development, Manufacturing Development, Regulatory Affairs, or Quality Assurance. You are eager to expand your skillset and address multifaceted technical challenges.

You possess:

• A master’s degree in life sciences (human biology, pharmacy, chemistry, engineering, or similar).
• Experience with design control and a special interest in defining product requirements.
• Strong interpersonal skills and you thrive working with many stakeholders.
• Ability to translate technical lingo into understandable language for non-experts.
• Ability to see the big picture while managing details.
• Excellent facilitation, planning and coordinating skills.
• A broad technical understanding and problem-solving skills.
• Knowledge of the risk management process according to ISO 14971.
• Excellent interpersonal abilities and a “can-do” attitude, thriving in a dynamic, fast-paced environment.
• Strong communication skills in English, both oral and written.

WE OFFER A TRULY PURPOSE DRIVEN WORKPLACE WHERE YOU CAN HAVE REAL IMPACT

We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun
Some of the facts and a little piece of history
Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global MedTech partners. New ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements.