Instrument engineer – IVD Product Development and Maintenance / onsite Hillerød

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 are a carve-out of the Danish Serum Institute and now owned by a private equity fund.

We are founded on the success of strong organic growth and acquisition of 3 clinical diagnostic companies. We recently signed off a new 5-year strategy for the group embarking on a journey to become one global IVD Diagnostic powerhouse. 

SSI Diagnostica group offers a wide range of rapid tests to help clinicians set the right diagnosis within the areas of respiratory, gastric and blood borne diseases. To ensure an objective reading of the results and to offer an option to transfer results to a laboratory information system (LIS), we have recently introduced a reader instrument to the market (ImmuView® Reader). We are experiencing an increased need from the market for adding additional rapid assays to the reader and are therefore expanding our R&D team with a Design owner of the reader instrument. 

The Team & the Position – Research & Development, Hillerød

You will be reporting to Head of R&D Hillerød and be part of a R&D team of very skilled colleagues with diverse backgrounds and competencies but with a passion for diagnostics in common. The variability of the tasks in our group is wide as we support all phases of development and sustainment of our product portfolio and collaborate with all departments in our global organization. As the design owner of the reader instrument portfolio, you will be the direct link between our contract developer/manufacturer and the instrument development projects as well as to the maintenance activities of the launched ImmuView® Reader. You will work closely across the global rimtopmaæ areas  and play a key role in our goal of expanding our reader business. 

Your areas of responsibilities: 

• Technical lead/design owner of the reader instrument for our rapid tests including direct technical contact to contract developer/manufacturer 
• Reviewing and approving documents from contract developer/manufacturer
• Participating in cross site and cross functional projects involving the ImmuView® reader, including hands-on adaptation for new assays and introducing the reader instrument to new markets
• Feasibility studies of new assays on the reader platform in collaboration with our lab technicians 
• Design verification and validation of final reader system in collaboration with our lab technicians
• Design transfer of new reader versions to operations
• Collaboration with sales and marketing when we have software updates to instruments in the market
• Leading change control activities related to the instrument internally and towards contract developer/manufacturer
• Participating in maintaining parts of our technical documentation, e.g., risk management file of the reader instrument
• Participating in maintaining our QMS on requirements to IVDs with hardware and software
• Supporting the R&D team in continuously improving our way of working  

Personal Qualifications:

• Relevant academic degree within biomedical engineering (e.g. Master of Science in medical engineering, electrical engineering or similar) 
• Minimum 5 years of experience from medical device or IVD industry
• Experience with development of instruments (including software, hardware and sensors) from early concept to commercialization and design maintenance
• Skilled within Design control (ISO 13485, 21 CFR 820), risk management (ISO 14971), human factor engineering (ISO 62366), software standards (IEC 62304) and standards within electrical safety, EMC and ESD (IEC 60601 and 61010 series) 
• High level knowledge of relevant programming languages e.g. C#, C++, C. including hands-on experience with smaller software scripting/adaptation tasks
• Excellent written and spoken English
• Thrive in cross cultural and cross functional collaborations 
• Self-starter with drive and energy to take on tough challenges and take them through to conclusion
• Uses a structured and systematic approach to deliver results  
• Extra bonus if you have:
  • Experience in immunoassay design and development
  • Experience with cybersecurity
  • Experience with software interoperability/interface standards at hospitals (HIS/LIS)
  • Knowlede of Danish in writting and speaking 

We look forward to hearing from you!