Head of Production

At Vivalyx, a medical technology startup based in Aachen, we're on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to significantly improve the vitality and availability of donor organs. As we are scaling, we're seeking a Head of Production – Omnisol (m/f/d) to join us starting as soon as possible, for 32-40 hours per week.

We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.

The Head of Production – Omnisol will build and lead the production and operational setup required to ensure sufficient, reliable, and quality-assured supply of Omnisol for patients and physicians across Europe. In the near term, the role will act as our on-site production interface at the external manufacturer, ensuring that current smaller-scale production runs smoothly and meets our quality and supply expectations, while supporting the implementation of sales- and logistics-supporting processes. In parallel, the role will lead the build-up of a scaled production model, including process design, supplier setup, production scale-up, facility build-up, validation, and operational readiness to support growing demand across the European market.

The position sits within a regulated European medtech environment and requires close collaboration with regulatory and quality functions to ensure that production-related activities are established and maintained in line with applicable ISO standards, the European Pharmacopoeia, and the requirements of the EU Medical Device Regulation (MDR; Regulation (EU) 2017/745).

Tasks

The Head of Production – Omnisol will establish the production and operational foundation needed to supply the European market reliably and at scale. In the near term, the role will act as Vivalyx’s on-site interface at our external manufacturer, helping ensure smooth smaller-scale production, quality-assured output, and the implementation of sales- and logistics-supporting processes. In parallel, the role will shape the future scaled production setup, including production capacities, processes, partner structures, operational controls, validation, and production readiness.

The role requires comfort moving between strategic production decisions, cross-functional coordination, external manufacturer management, and hands-on resolution of operational issues in a regulated European environment.

Requirements

The ideal candidate brings substantial experience in production, operations, and scale-up within a regulated environment and is comfortable taking responsibility in a setting where structures are still being built. The role requires a strong combination of strategic thinking, implementation discipline, and sound judgment.

This position would suit someone who is able to translate complex requirements into robust processes, navigate ambiguity without losing momentum, and work effectively across technical, operational, regulatory, and external stakeholder interfaces. A background that combines STEM or laboratory exposure with experience in structured problem-solving environments, including consulting, could be highly relevant if paired with sufficient operational credibility and implementation strength.

Required Qualifications

• Passion for working in medical technology development
• Strong sense of ownership, reliability, and attention to detail
• Confidence in identifying issues early, speaking up when needed, and driving decisions in a constructive and solution-oriented manner.
• Fluent in English, both written and spoken (German is a strong plus)
• Degree in engineering, life sciences, chemistry, bioprocessing, operations, or another relevant technical or scientific discipline.
• Significant professional experience in production, manufacturing, operations, or process scale-up in a regulated environment.
• Experience working within or alongside quality and regulatory requirements relevant to the European medtech, healthcare, or life sciences market.
• Proven experience building or scaling production-related processes and infrastructure.
• Experience working with external suppliers, manufacturers, or other critical operational partners.
• Ability to work on-site at least twice a week in our production facility next to Berlin

Preferred Qualifications

• Experience in start-up or high-growth environments.
• Experience in the European medtech, medical device, biotech, or broader regulated life sciences sector.
• Familiarity with the EU Medical Device Regulation (MDR; Regulation (EU) 2017/745) and its practical implications for production and operations.
• Familiarity with applicable ISO standards and the European Pharmacopoeia in a production-related context.
• Experience with validation, facility setup, and production investment planning.
• Experience working with CMOs or other outsourced manufacturing models.
• Experience building supply-relevant operational structures in an evolving organization.
• Previous experience in consulting may be valuable where combined with relevant technical training and clear evidence of hands-on implementation capability.

Benefits

We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.

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