Design & Development Specialist
Would you like to take responsibility for design control, risk management, and support a broad range of operations projects by ensuring coherent risk documentation for the product and manufacturing?
If so, you can embark on a career journey with a growing company and further advance in your career.
About Ferrosan Medical Devices A/S
Ferrosan Medical Devices A/S develops and produces a portfolio of hemostatic products to aid surgery in minimizing bleeding challenges (Surgiflo®). Products are registered as medical devices (Class III). They are sold internationally in over 100 countries in close collaboration with the main customer partner, Ethicon Biosurgery, part of Johnson & Johnson. Ethicon Biosurgery is also our innovation partner and plays a strong role in providing extensive knowledge about global market needs to ensure that we always have a strong and competitive product portfolio.
All main functions in the Ferrosan Medical Devices company are in Søborg, DK, including production facilities. Hence, everyone sits door to door with easy access to each other. The company is growing and has a long-term strategy that involves several early and late-stage product development projects discovering the next-generation hemostatic products.
The Product Development department
The Product Development department is under New Business Development and comprises 18 employees organized into 3 specialist teams: Design & Development (9), Biosafety & Labelling team (7), and Product Owners (2). The Product Development department is responsible for the coordinating and executing the design control and risk management processes in both development project and life cycle management projects. In projects, the design control specialist, sets technical requirements, and manages design input, outputs, verification, and validation as well as managing the risk process. They compile technical evidence to ensure designs meet Class II and III product standards for functionality, efficiency, and safety, working with cross-functional teams from conception to launch. Documentation contains traceability data from user needs, through design input and output, to design verification and validation, and must be systematically documented to be in regulatory compliance.
The department also plays an important role in projects related to operations/manufacturing, production deviations, product complaints, or requests from Ethicon Biosurgery related to product functionality, making a very dynamic function.
The department has diverse backgrounds and experiences and shares best practices from the various projects they participate in continuously. The teams are highly self-driven and significantly influence daily priorities, making it more empowering for everyone. The department is also organized into SME (Subject Matter Expert) groups.
You will report to Product Development Director Mette Krog Keller.
Your role
A significant focus of your role will be on risk management, demanding a collaborative spirit and a flexible approach engaging in general problem-solving to support the projects overall objectives and find solutions.
You will support various operations projects and contribute to creating processes and assessments around risk management, including processes for control strategies. You will work with risk management as a cyclical and dynamic process. The projects cover capacity expansion; new equipment needs to be purchased, new clean rooms and a new production line being established, just to mention some of the ongoing and coming projects.
You will also use your broader skillset by sometimes encompassing one or more of the following key positions based on the scope and complexity of the project or change: Design Control Coordinator, Design Risk Manager, and Design Verification Specialist. This makes your role specialized but, at the same time, also broad, preventing you from being stuck in a silo.
Your role will include:
- Planning, coordinating, and reporting the product risk management process in projects to create coherent and compliant risk management files 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.
- Led project planning efforts and diligently monitored the project’s progression within the Design Control framework.
- 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 most likely have a background in medical devices, perhaps in combination with pharma, and you are scientifically skilled. Most importantly, you have the knowledge and experience to dive into complex issues and address multifaceted technical challenges to find solutions.
You must be eager to be profoundly involved in risk management, showing a keen interest in this field, and desiring to delve further into this focus area.
We are open to various backgrounds for this role, including Research & Development, Manufacturing Development, Process Engineering, Process validation, or similar roles.
Regardless of your background, you should want to broaden your skillset and be involved in identifying product risks and implementing risk controls to ensure that changes to equipment or processes do not compromise the product’s safety or efficacy.
You are a team player, comfortable covering a broad area of responsibility with many parallel tasks and deadlines. You identify and analyze problems and state and discuss your conclusions with an open mind toward others’ opinions. You propose solutions clearly, and you can maintain the overview in an often dynamic environment where you must prioritize and decide to move forward.
In addition, your profile contains:
- A master’s degree in science or engineering.
- 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.
Ferrosan Medical Devices as a workplace
An international organization with about 280 employees and a strong collaborative culture with solid Danish roots. An environment where you discuss matters with your colleagues and key stakeholders and can expect everyone to take responsibility for common results. The organization is flat and tone informal.
How to come into consideration
Please contact: Partner at Peoplement, Anne Borgen, either by mail at anne@peoplement.dk or at +45 6169 0101 for more information.
You can apply for the position using this link.
About Peoplement
Peoplement offers executive search and recruitment of executives, senior managers and key specialists within general management, sales, digital, marketing, finance, supply chain & operations, HR and IT.
Peoplement Denmark is the exclusive representative of AltoPartners, a leading international alliance of retained boutique entrepreneurial executive search and leadership consulting firms.
Peoplement P/S
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DK 2900 Hellerup, Denmark
