Save Job Back to Search Job Description Summary Similar Jobs Added 19/05/2026Key role in transferring novel IVD assays from R&D to productionDirect impact on globally used immunodiagnostic productsAbout Our ClientOur client is a growing European developer and manufacturer of in‑vitro diagnostics, operating at the intersection of science, healthcare and production. The organisation combines strong in‑house expertise with a collaborative, multidisciplinary culture focused on reliable diagnostics for laboratories worldwide.Job DescriptionYou are responsible for designing, improving and transferring robust production processes for new diagnostic products. Working closely with R&D, Production, Quality and Regulatory Affairs, you ensure scalability, compliance and reproducibility.Develop and optimise manufacturing processes during product developmentAct as the technical link between R&D and Production during tech transferPlan, execute and document experiments according to ISO 13485 standardsSupport pilot runs and feasibility studies for new IVD assaysApply DoE, FMEA and control plans to improve yield and process robustnessImplement tools for automated analysis of production and process dataMonitor and assess new production and assay technologiesThe Successful ApplicantYou bring senior‑level experience in IVD process development and are comfortable taking ownership in multidisciplinary teams. You combine structured thinking with pragmatism and clear communication.Master's or PhD in Life Sciences, Biochemistry or Chemical Engineering5-10 years' experience in process development within IVD or medical devicesProven experience with tech transfer from development to manufacturingStrong knowledge of ISO 13485, IVDR and/or FDA regulated environmentsHands‑on experience with DoE, PDCA, FMEA, IQ/OQ/PQAble to lead projects and communicate clearly across functionsProactive, structured and commercially aware mindsetWhat's on OfferCompetitive salary aligned with seniority and experience36‑hour full‑time contract with flexible working arrangements8.33% holiday allowance and 8.33% year‑end bonusExtensive training and development opportunities in diagnosticsWork on products with real clinical impact and global reachContactKaitlyn HalleranQuote job refJN-052026-7019951Job summarySectorEngineering & ManufacturingSub SectorSix Sigma, Lean, Process improvementIndustryHealthcare / Pharmaceutical Jobs by locationUtrechtContract TypePermanentConsultantKaitlyn HalleranJob ReferenceJN-052026-7019951
