Experienced Design Control Specialist
SSI 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. We offer a wide range of rapid tests to support clinicians in making timely and accurate diagnoses in areas such as respiratory, gastric, and blood-borne diseases. 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, Hillerød
You 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)
- Hands on experience in risk management (EN ISO 14971), IVDR, and human factors engineering (IEC 62366-1)
- Track record in developing immunoassays/rapid tests from concept to commercialization and ongoing design maintenance
- 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 Workplace
You’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 tasks
Interested?
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 Group
At 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.
