Senior Manufacturing Engineer

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.

Ready?

Apply below! We review on a rolling basis and move quickly for the right person.