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België

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2026-05-14

Online to:

2026-07-13
EUR 20.00 HOUR

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Medical Device Engineer (Combination Products)

BioTalent
België
Andere
2 weken geleden

We are supporting a global pharmaceutical organisation in hiring a Medical Device Engineer to support the design, development, industrialisation and lifecycle management of drug delivery systems. The role sits within a multidisciplinary device organisation and works closely with internal programme teams and external partners across global projects. Key Responsibilities: Support design, development and industrialisation of drug delivery devices from NPI through lifecycle management Ensure compliance with medical device regulations and GMP for combination products Contribute to device verification, validation, process validation and regulatory submissions Support creation and maintenance of Design History Files (DHF) Coordinate technical activities with internal stakeholders and external suppliers Support post‑market activities, change management and secondary regulatory submissions Contribute to evaluation of new device technologies and platforms Requirements: ~ Degree in Engineering or related scientific discipline ~3+ years’ experience within pharma, biotech or medical devices ~ Strong knowledge of ISO 13485, ISO 14971, MDR, 21 CFR 820, 21 CFR 4 ~ Experience with combination products and GMP environments ~ Strong communication skills in cross‑functional and matrix teams Nice to Have: Project management or Green Belt certification Experience working with external device manufacturers or CDMOs

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