Senior IVD Process Engineer: Tech Transfer&Scale-Up, Utrecht
Senior IVD Process Engineer: Tech Transfer&Scale-Up, Utrecht
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Utrecht, Nederland -
Geplaatst op: 1 week geleden
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Onthouden -
Delen
Advertentietekst
Key role in transferring novel IVD assays from R&D to production Direct impact on globally used immunodiagnostic products
Firmenprofil 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.
Aufgabengebiet 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
Anforderungsprofil
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
Vergütungspaket
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
Kontakt Referenznummer: JN-052026-7019951
#J-18808-Ljbffr
Firmenprofil 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.
Aufgabengebiet 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
Anforderungsprofil
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
Vergütungspaket
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
Kontakt Referenznummer: JN-052026-7019951
#J-18808-Ljbffr
Belangrijke informatie
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BedrijfsnaamMichael Page -
PositieSenior IVD Process Engineer: Tech Transfer&Scale-Up
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