Senior Manufacturing Engineer

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

Turn a CE-marked breakthrough into a manufacturing line.

Xeltis builds regenerative cardiovascular devices: implants engineered to be gradually restored by the patient’s own living tissue. In April 2026 our lead device, aXess™, reached CE mark. We are now moving from clinical-stage development into commercial-scale production, and that transition is the single most important thing happening in the company right now.

That is the job.

You will own the industrialisation of a device that has never been made at commercial volume before. Not maintaining a mature line. Building one.

Key Responsibilities

Manufacturing Scale-Up & Process Development

• Lead manufacturing process 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 that ensure consistent product quality.

Technical Leadership

• Provide technical guidance and mentoring to manufacturing engineers and technicians.
• Lead cross-functional problem solving and decision-making activities.
• Collaborate closely with R&D, Quality, Validation, and Operations teams to align manufacturing goals and priorities.
• Act as a subject matter expert on manufacturing process performance and capability.

Validation & Regulatory Compliance

• Lead manufacturing validation activities, including IQ, OQ, and PQ protocols.
• Support internal audits, external inspections, and regulatory submissions.
• Ensure manufacturing documentation, procedures, and controls comply with GMP and quality system requirements.
• Maintain focus on product quality, patient safety, and regulatory readiness.

Continuous Improvement

• Identify opportunities to improve manufacturing performance and process capability.
• Reduce process variability, waste, and operational inefficiencies.
• Implement Lean Manufacturing and continuous improvement methodologies where appropriate.
• Drive initiatives that enhance yield, productivity, and cost efficiency.

Technology Transfer & Industrialisation

• Lead the transfer of new products and processes from R&D into manufacturing.
• Develop manufacturing readiness strategies for new technologies.
• Support equipment selection, process development, and industrialisation projects.
• Ensure successful integration of innovative technologies into routine manufacturing operations.

Troubleshooting & Risk Management

• Lead investigations into process deviations and manufacturing issues.
• Conduct root cause analyses using structured problem-solving methodologies.
• Develop and implement risk mitigation strategies.
• Support rapid response activities to minimise production disruptions

What You'll Bring

Essential Qualifications & Experience

• Bachelor’s or Master’s degree in manufacturing engineering, Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biotechnology, or a related discipline.
• Significant experience (7+) in manufacturing engineering within a regulated industry such as medical devices, biotechnology, pharmaceuticals, or life sciences.
• Proven experience supporting manufacturing scale-up and process optimisation.
• Strong understanding of GMP, process validation, and quality management systems.
• Experience leading cross-functional engineering projects and technical improvement initiatives.
• Demonstrated success in technology transfer and industrialisation projects.

Technical Expertise

• Process development and optimisation
• Manufacturing scale-up and technology transfer
• Process validation (IQ/OQ/PQ)
• Root cause analysis and troubleshooting
• Statistical process control and process capability analysis
• Risk assessment methodologies
• Lean Manufacturing and continuous improvement techniques
• GMP and regulated manufacturing environments

Soft Skills & Leadership Attributes

We are looking for an individual who combines strong technical expertise with outstanding leadership and collaboration skills:

• Excellent analytical and problem-solving abilities.
• Strong communication and stakeholder management skills.
• Ability to influence and lead across multidisciplinary teams.
• A proactive and structured approach to identifying and resolving technical challenges.
• Strong organisational and project management capabilities.
• Passion for continuous improvement and operational excellence.
• Ability to mentor and develop colleagues while fostering a collaborative culture.