Design & Development Specialist
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Søborg
Design & Development Specialist
Do you want to be a part of the Product Development Department 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 3rd 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 focus on Design Control
The Product Development department consists of 16 employees organized into 3 specialist teams: The Design & Development team, The Biosafety & Labelling team, and Product Owners.
As a Design & Development Specialist you will mainly be allocated to development projects. In our project portfolio we have a variety of projects within, for instance new product development, line extension, optimization (both Process and Product) and capacity expansion projects.
In projects, we oversee Design Control, set technical requirements, and manage design input, outputs, verification, and validation. We compile technical evidence to meet Medical Device Class II and III requirements. All solutions are documented and accurately described in accordance with Design Control and/or GDP. Broad collaboration and stakeholder management with the rest of the organization is a necessity to succeed.
Your role
When allocated to projects you can have the following roles: A Design Control Coordinator, Design Risk Manager and Design Verification Specialist. You can either have one, two or all three roles depending on the size and complexity of the project. When you are a team member in a project you are a representative of the department and act as a team player, i.e., you are always open-minded and help find solutions together with the team even though this might fall outside of the defined roles above.
Your role will include:
About you
You have a background within the Medical Device Industry, perhaps in combination with pharma. You have worked in e.g., Research and Development, Regulatory Affairs, or Quality Assurance or similar with new product development in focus. Regardless of your background, you are looking to broaden your skillset by working in product development with a biologically complex combination of products/devices and many interesting, complex issues to be tackled.
Other than the above, you have:
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
Do you want to be a part of the Product Development Department 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 3rd 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 focus on Design Control
The Product Development department consists of 16 employees organized into 3 specialist teams: The Design & Development team, The Biosafety & Labelling team, and Product Owners.
As a Design & Development Specialist you will mainly be allocated to development projects. In our project portfolio we have a variety of projects within, for instance new product development, line extension, optimization (both Process and Product) and capacity expansion projects.
In projects, we oversee Design Control, set technical requirements, and manage design input, outputs, verification, and validation. We compile technical evidence to meet Medical Device Class II and III requirements. All solutions are documented and accurately described in accordance with Design Control and/or GDP. Broad collaboration and stakeholder management with the rest of the organization is a necessity to succeed.
Your role
When allocated to projects you can have the following roles: A Design Control Coordinator, Design Risk Manager and Design Verification Specialist. You can either have one, two or all three roles depending on the size and complexity of the project. When you are a team member in a project you are a representative of the department and act as a team player, i.e., you are always open-minded and help find solutions together with the team even though this might fall outside of the defined roles above.
Your role will include:
- Defining Design Requirements and manage Design Inputs and Outputs
- Performing Design Verification
- Performing Design Reviews and Design Transfer
- Managing traceability and storyline across the technical documentation
- Managing product risk management incl. creating the Hazard Traceability Matrix
- Project Planning activities and taking responsibility for tracking project status within Design Control
About you
You have a background within the Medical Device Industry, perhaps in combination with pharma. You have worked in e.g., Research and Development, Regulatory Affairs, or Quality Assurance or similar with new product development in focus. Regardless of your background, you are looking to broaden your skillset by working in product development with a biologically complex combination of products/devices and many interesting, complex issues to be tackled.
Other than the above, you have:
- An academic background: master’s degree in life sciences (human biology, pharmacy, chemistry, engineering or similar)
- Design Control experience
- Broad technical understanding
- A sense for the detail
- A “can-do” attitude and you thrive in a dynamic environment
- Strong interpersonal skills and you thrive working with many stakeholders.
- An ability to put your own work into a cross-functional reference.
- Strong oral/written communication skills in English.
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 11.9.2023, 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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