Manufacturing Scale-Up Lead – Medical Devices

Xeltis; Eindhoven; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Xeltis is transitioning from clinical development to commercial-scale production. You will own the industrialisation of a device never before made at volume, building a scalable manufacturing line with robust processes and cross-functional alignment.

You will lead scale-up, technology transfer, validation (IQ/OQ/PQ), continuous improvement, and risk management while mentoring engineers and collaborating with R&D, Quality, Validation, and Operations to ensure GMP compliance and patient safety.

Qualifications

• Bachelor’s or Master’s degree in manufacturing/biomedical engineering or a related discipline.
• 7+ years of experience in manufacturing engineering within regulated life sciences environments.
• Proven track record in manufacturing scale-up, process optimisation, and technology transfer.

Responsibilities

• Lead manufacturing process scale-up activities to support increased production volumes.
• Provide technical leadership and mentoring to manufacturing engineers and technicians.
• Drive process validation activities (IQ/OQ/PQ) and ensure GMP compliance.
• Identify opportunities for Lean improvements to reduce variability and waste.
• Lead technology transfer and industrialisation projects from R&D into manufacturing.
• Manage investigations into process deviations and implement risk mitigation strategies.

Skills

Manufacturing Engineering

GMP Compliance

Process Validation

Lean Manufacturing

Technology Transfer

Risk Analysis

Education

Bachelor’s or Master’s degree in related field

Job description

Xeltis is transitioning from clinical development to commercial-scale production. You will own the industrialisation of a device never before made at volume, building a scalable manufacturing line with robust processes and cross-functional alignment.

You will lead scale-up, technology transfer, validation (IQ/OQ/PQ), continuous improvement, and risk management while mentoring engineers and collaborating with R&D, Quality, Validation, and Operations to ensure GMP compliance and patient safety.