Design & Development Specialist (2700)
Ferrosan Medical Devices A/S
Design & Development Specialist
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 impact the production and development of our products, but 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!
Design & Development Specialist with Risk Management focus
We offer a role as a Design & Development Specialist, where you will be responsible for Product Risk Management activities in projects and during product maintenance. Your responsibilities will vary from executing tasks to leading product Risk Management activities within projects. Additionally, you may be assigned improvement tasks within product maintenance to ensure compliant product documentation. In both cases, you are expected to plan and coordinate with your immediate stakeholders, keeping them informed about deadlines, potential delays, and project risks. While your primary focus will be on Product Risk Management, you will also take on other roles within Design Control as needed. This requires a broad understanding of Design Control and flexibility to adapt to various tasks and responsibilities.
In Product Development (PD), we oversee design control activities across all aspects of development projects, from device development to launch. Additionally, we ensure the safety, performance, and functionality of our products (Class II and III medical devices, including combination products) and maintain the technical documentation. PD also upholds product safety and effectiveness post-launch during market expansion projects, capacity expansion projects, and design or component changes. We create and maintain the product risk management file, ensure compliance with relevant standards and regulations, and own the design history files and device change logs.
Our team operates on self-managing principles, placing a high level of autonomy and responsibility on specialists. Our vision is to make decisions where the knowledge resides, ensuring that decision-making is as agile and fast as possible.
Job description
We are seeking an organized and skilled Design & Development Specialist to join our team. The ideal candidate will play a crucial role in ensuring that our design processes meet regulatory standards and maintain the highest levels of quality.
Your role
- Support the work of defining Design Requirements
- Facilitate, plan and report product Risk Management activities
- Support the preparation and submission of regulatory filings related to design controls and risk management
- Execute relevant Design Control activities when needed
- Examples of such could be creating/updating specifications, reviewing protocols/reports, analyzing standards, Writing rationales, etc.
- Take part in project planning to understand the overall project deliverables and dependencies
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 risk management (ISO 14971)
- Experience with design control (ISO 13485:2016 and 21 CFR part 820.30)
- Strong interpersonal skills and thrive working with many stakeholders.
- Ability to translate technical language into understandable terms for non-experts.
- Capability to see the big picture while managing details.
What we offer
We offer a truly purpose-driven workplace with strong roots in values. We are driven by improving patient outcomes and 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 a real impact and a development curve that you can steepen at a pace suitable for you. You will meet a DK-rooted company growing in the 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 😊
Want to join our team?
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