Senior Manfacturing Engineer

Xeltis; Eindhoven; On-site; 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

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?