Senior Design & Development Specialist
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Søborg
Senior Design & Development Specialist with PM skills
Do you want to be a part of Product Development in a company with a unique impact on global healthcare? If you are passionate about both Design Control and project management, then we have the perfect role for you. 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 Control & Project Management
We offer a role as a Design & Development Specialist that will also focus on Project Management in our development projects. You will not only excel as a Design Control specialist but also be responsible for planning, coordinating, and overseeing design control activities in projects. You are expected to manage Design Control activities and execute Design Control tasks effectively.
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
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
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?
Send your application along with your CV on March 23rd at the latest. We will process the applications as we receive them, and the job ad will be renewed until the right candidate has been found.
We look forward to hearing from you.
Read more about us here
Do you want to be a part of Product Development in a company with a unique impact on global healthcare? If you are passionate about both Design Control and project management, then we have the perfect role for you. 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 Control & Project Management
We offer a role as a Design & Development Specialist that will also focus on Project Management in our development projects. You will not only excel as a Design Control specialist but also be responsible for planning, coordinating, and overseeing design control activities in projects. You are expected to manage Design Control activities and execute Design Control tasks effectively.
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
- Facilitate Design Control planning in a cross-functional team setting.
- Communicate and coordinate actively with all relevant stakeholders and track actions closely.
- Responsible for creating and maintaining the Design & Development Plan & DHF index.
- Support the preparation and submission of regulatory filings related to Design Control.
- Execute relevant Design Control activities when needed.
- Examples of such could be creating/updating specifications, reviewing protocols/reports, analyzing standards, writing rationales, etc.
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 (ISO 13485:2016 and 21 CFR part 820.30).
- Understanding of risk management (ISO 14971).
- Strong interpersonal skills and thrive working with many stakeholders.
- The ability to translate technical language into understandable terms for non-experts.
- Capability to see the big picture while managing details.
- Excellent facilitation, planning, and coordinating skills.
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?
Send your application along with your CV on March 23rd at the latest. We will process the applications as we receive them, and the job ad will be renewed until the right candidate has been found.
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 4.3.2025, 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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