Senior Design & Development Specialist
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Søborg
Senior Design & Development Specialist
Do you want to take on responsibility for the verification and validation activities to ensure product performance requirements across our portfolio of haemostatic products? We are continuously working to adapt to new challenges – and we are developing our verification and validation processes to support future products and regulatory requirements. We hope you want to join us on this journey.
We are ready to invest in you. At Ferrosan Medical Devices 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!
Senior Design & Development Specialist – for our Product Development Department
You will join a dynamic environment, with varied tasks in our Product Development team that consists of 14 experienced professionals, diverse in both skill sets and backgrounds. We work with dedication to deliver state-of-the-art product documentation.
We own the product design documentation; hence we must ensure Life Cycle Management of the product documentation and current regulatory compliance. We provide support on product safety, risk management and product performance in development of new products and production of legacy products. We are also involved in material changes, process changes, deviations in the production, complaints regarding product design – and we support our partner Ethicon Biosurgery in requests on product functionality or verification matters.
In development projects, we are responsible Design Control, including preparation of design input and outputs, and design verification and validation.
We define technical requirements for the product documentation in accordance with Design Control and prepare technical evidence, rationales, and data to ensure product design meets required functionality, efficiency, and safety of Class III products. This involves working in cross-functional teams from early phase product development until product launch.
Your role
The role is broad, and you will be involved in cross functional projects and in a product development project, driving design verification, setting acceptance criteria, defining test and stability requirements in accordance with regulatory requirements.
You will drive continuous improvement of technical documentation on our legacy products, so you need to have a scientific mindset and skills within documentation and Risk Management in general.
Our documentation contains traceability data from user need, through design input and output, to design verification and validation, and must be systematically documented. You will make use of your scientific curiosity and problem-solving nature daily.
Your role will include
- Development activities focusing on product performance, i.e. design verification and validation.
- Product Risk assessments and Design Control activities.
- Finding technical solutions to product issues within materials and design.
- Preparing performance studies and technical rationales etc.
- Responsibility for protocol writing, practical execution, and reporting of test activities.
- Participation in general development activities, i.e., development studies, technical evaluations, or regulatory rationales.
- Participation in Life Cycle Management of legacy products, focus on product safety and effectiveness
About you
You have the knowledge and experience to dive into complex technical issues and take a scientific approach to come up with solutions. By nature, you are both a problem solver and trouble-shooter and understand technical issues, that may not be within your scientific specialities but could be related to production processes.
You usually find pragmatic solutions, however, take risk assessment and legislation into consideration.
You are looking to broaden your skillset by working in product development with a biologically complex combination product and many interesting issues. You are a team player and comfortable covering a broad area of responsibility with many parallel tasks and deadlines. You identify and analyse problems, state your conclusions, and propose solutions clearly and you can maintain the overview in a dynamic environment where you need to prioritize and make decisions.
In addition, your profile contains
- A master’s degree within life sciences, e.g., human biology, pharmacy, chemistry, engineering
- Experience within Medical devices or Pharma.
- Perhaps, a background within Research & Development, Project Engineering/Manufacturing Engineering, Quality Assurance
- Design Control experience or willing to learn.
- Broad technical understanding and detailed orientated.
- You are curios, self-driven and thrive working with many different stakeholders.
- You have strong interpersonal skills, and collaborating personality
- 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 haemostatic 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 as soon as possible. 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 8.12.2022, 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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