Senior Manufacturing Engineer

Role description

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.

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

• 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.

• 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.

• 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.

• 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.

• 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

• 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.

• 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

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. xgiwjmb
• Ability to mentor and develop colleagues while fostering a collaborative culture.