Design Control Specialist – R&D / Hillerød
- Hillerød Design Control Specialist – R&D / Hillerød Apply for this job Experienced Design Control SpecialistSSI Diagnostica Group is a clinical diagnostic company with a mission to help prevent, monitor, and diagnose clinical diseases through our quality portfolios of reagents and IVD diagnostic products and solutions.
To ensure objective result interpretation and enable integration with laboratory information systems, we have recently introduced the ImmuView® Reader instrument.
Due to growing market demand for additional IVD assays compatible with the reader, we are expanding our R&D team with a Design Control Specialist to support design control and documentation of new assays developed across the global SSI Diagnostica Group.The Team & the Position – Research & Development, HillerødYou will report to the Head of R&D in Hillerød and join a team with broad expertise
- from protein chemistry to system engineering
- and with a passion for in vitro diagnostics in common.
Our group supports all phases of product development and maintenance across the portfolio.
As the design specialist for new assays developed for the reader portfolio, you will be the main point of contact for both our external assay contract developer/manufacturer and our internal R&D assay development team.You will collaborate closely with our system engineer responsible for the ImmuView® Reader and with global functional teams, contributing directly to the growth of our reader business.Your areas of responsibility Reviewing and approving design control documents from contract developer/manufacturer Generating internal design control documentation and leading design reviews for new assays Supporting the final compilation of technical documentation in collaboration with relevant stakeholders Participating in cross-site and cross-functional projects involving new assay development for the ImmuView® Reader Writing protocols and reports for feasibility and usability studies in collaboration with lab technicians and/or external partners Leading design verification and validation of assays within the final reader system Managing design transfer of new assays to operations Maintaining technical documentation for assays and the Reader system Contributing to updates and improvements in our QMS, particularly within design control Supporting the R&D team in refining and evolving our processes Your qualifications Academic background in protein chemistry/immunoassays (e.g., MSc in Science, Engineering, Pharmacy, or similar) Minimum 5 years of experience in the medical device or IVD industry Extensive expertise in design control (EN ISO 13485, 21 CFR 820) Experience in risk management (EN ISO 14971), IVDR, and human factors engineering (IEC 62366-1) Experience with immunoassays and/or clinical microbiology Fluent in English, both written and spoken Comfortable working across cultures and disciplines, with the ability to build shared understanding in complex projects Methodical and detail-oriented, with a clear focus on quality and documentation Bonus qualifications Experience in developing medical device instruments (hardware- and software) Our Culture and WorkplaceYou’ll be part of an environment where care, competence, and collaboration are at the heart of how we work.
We value openness, helpfulness, and pride in what we do – and you’ll experience that in your daily interactions across departments.Our Hillerød site offers access to a fitness center, a staff canteen, and free parking.
While the role is primarily on-site, remote work days can be arranged based on mutual agreement and the nature of the tasksInterested?
If you have any questions, please contact Lene Karin Jespersen, Head of R&D Hillerød, at lkj@ssidiagnostica.com or mobile: +45 61209703.Please apply via the application button as soon as possible and no later than October 15.
We expect to conduct interviews shortly after the application deadline.About us – SSI Diagnostica GroupAt our Hillerød site, we are approximately 135 colleagues working across production, development, and support functions.
The site plays a central role in our global operations and innovation efforts.
With roots in the Danish State Serum Institute and a growth journey shaped by the acquisition of four clinical diagnostic companies, we combine a strong heritage with a clear purpose: improving vitality and health in communities worldwide.
Department Research and Development (R&D) Role Specialist Locations Hillerød Contact Inge Trier Global Talent Acquisition Manager – Human Resources
- DK Hillerød A unique career
- Join us About SSI Diagnostica Group SSI Diagnostica Group, a global leader in infectious disease clinical diagnostics, was originally established as a division of the prestigious Danish National Reference Center – Statens Serum Institut.
The company employs over 600 people across the globe and offers innovative solutions for disease surveillance, diagnosis, outbreak investigation, and quality control in three key areas: gastric, respiratory, and bloodborne diseases.With administrative and manufacturing facilities located in Denmark, the United States, and China, and a strong global network of distribution partners, the SSI Diagnostica Group continues to build its position as a leading supplier of reagents and in vitro diagnostic (IVD) products worldwide.
Founded in 1902 Coworkers 650 globally Apply for this job Research and Development (R&D)- Hillerød Design Control Specialist – R&D / Hillerød Loading application form Career site Jobs People Locations Back to front page Data & privacy Manage cookies Locations Dublin Blacksburg Hillerød Poway Radford Remote ssidiagnostica.com/ Employee login
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