Industrialization Engineer: Medical Device Scale-Up Leader

Xeltis; Eindhoven; On-site; EUR 90,000 - 130,000; Full time

Job summary

Xeltis is transitioning from clinical-stage development to commercial-scale production of aXess, a CE-marked regenerative cardiovascular device. You will own the industrialisation of a device never produced at this volume, building a scalable manufacturing line and driving process improvements across functions.

Join a team that partners with R&D, Quality, Validation and Operations to ensure GMP compliance, robust validation, and risk management while delivering quality and patient safety.

Qualifications

• Bachelor’s or Master’s degree in manufacturing or related engineering field.
• 7+ years of manufacturing engineering experience in regulated industries.
• Experience with scale-up, process optimization, and technology transfer.
• Strong GMP, validation, and quality management systems knowledge.
• Leadership of cross-functional engineering projects.
• Proven success in technology transfer and industrialisation.

Responsibilities

• Lead manufacturing scale-up activities to support increased production volumes.
• Develop and implement scalable manufacturing solutions.
• Drive process optimisation initiatives to improve efficiency and reproducibility.
• Establish robust process control strategies for consistent product quality.
• Provide technical guidance and mentoring to manufacturing teams.
• Lead cross-functional problem solving and decision-making activities.
• Collaborate with R&D, Quality, Validation, and Operations to align goals.
• Act as SME on manufacturing performance and capability.
• Lead manufacturing validation activities (IQ/OQ/PQ) and support audits.
• Ensure documentation, procedures, and controls meet GMP requirements.
• Maintain focus on product quality and regulatory readiness.
• Identify opportunities to improve performance and reduce waste.
• Drive Lean and continuous improvement for yield and cost efficiency.
• Lead technology transfer and industrialisation projects from R&D to manufacturing.
• Develop readiness strategies for new technologies.

Skills

Manufacturing scale-up

Process optimisation

GMP knowledge

Regulatory compliance

Cross-functional leadership

Lean manufacturing

Statistical Process Control

Technology transfer

Problem solving

Root cause analysis

Project management

Mentoring

Education

Engineering degree (Bachelors or Masters)

Job description

Xeltis is transitioning from clinical-stage development to commercial-scale production of aXess, a CE-marked regenerative cardiovascular device. You will own the industrialisation of a device never produced at this volume, building a scalable manufacturing line and driving process improvements across functions.

Join a team that partners with R&D, Quality, Validation and Operations to ensure GMP compliance, robust validation, and risk management while delivering quality and patient safety.