Sr. Process Developer IVD Diagnostics - Utrecht

Over onze klant

Our 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.

Functie

You 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 development
• Act as the technical link between R&D and Production during tech transfer
• Plan, execute and document experiments according to ISO 13485 standards
• Support pilot runs and feasibility studies for new IVD assays
• Apply DoE, FMEA and control plans to improve yield and process robustness
• Implement tools for automated analysis of production and process data
• Monitor and assess new production and assay technologies

Profiel

• Master's or PhD in Life Sciences, Biochemistry or Chemical Engineering
• 5-10 years' experience in process development within IVD or medical devices
• Proven experience with tech transfer from development to manufacturing
• Strong knowledge of ISO 13485, IVDR and/or FDA regulated environments
• Hands‑on experience with DoE, PDCA, FMEA, IQ/OQ/PQ
• Able to lead projects and communicate clearly across functions
• Proactive, structured and commercially aware mindset

• Competitive salary aligned with seniority and experience
• 36‑hour full‑time contract with flexible working arrangements
• 8.33% holiday allowance and 8.33% year‑end bonus
• Extensive training and development opportunities in diagnostics
• Work on products with real clinical impact and global reach