Design & Development Specialist
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Søborg
Design & Development Specialist – Risk Management and Design Control
If you're passionate about design control and risk management for medical devices and combination products and aspire to have 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.
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 are seeking a Design & Development Specialist to further our mission.
Join Our Dynamic Product Development Team
You will be a part of the Product Development department, which consists of 18 employees organized into 3 specialist teams: The Design & Development team (9), The Biosafety & Labelling team (7), and Product Owners (2).
You will play a pivotal role both within project teams and in ongoing operations. Whether assigned to a project, or supporting the current product line, your role may encompass one or more of the following key positions based on scope and complexity of the project or change: Design Control Coordinator, Design Risk Manager, and Design Verification Specialist. A significant focus of your role will be on risk management, demanding a collaborative spirit and a flexible approach. You should therefore be prepared to engage in problem-solving beyond the confines of your designated role to support the team's objectives.
Key responsibilities in your role include:
- Planning, coordinating, and reporting the product risk management process in projects to create coherent and compliant risk management file for existing and new products.
- Defining and optimizing design requirements and effectively managing risk controls, design input requirements and design outputs.
- Planning and executing design verification activities, such as analyses and tests.
- Conducting design reviews and facilitating the design transfer process.
- Leading project planning efforts and diligently monitoring the progression of the project within the framework of Design Control.
- Improving documentation to ensure clarity, compliance, and efficiency and to reflect updates throughout the product lifecycle.
- Supporting the improvement of our processes related to risk management.
The Ideal Candidate
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).
- Proven experience in Design Control and a special interest in product risk management.
- Strong interpersonal skills and you thrive working with many stakeholders.
- Excellent 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.
Want to join our team?
Send your application along with your CV. We will process the applications as we receive them.
Questions? Please do not hesitate to contact Anne Borgen, Managing Partner, Peoplement, on +4561690101.
We look forward to hearing from you.
Read more about us here
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 26.2.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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