Kuros Biosciences is a Swiss-listed life science company with offices in Bilthoven (The Netherlands), Atlanta (USA), and Schlieren (Switzerland). Kuros specializes in the development and marketing of orthobiologics for spinal fusion surgery, aimed at stabilizing the spine in patients with back issues. The bone repair products are developed and manufactured in Bilthoven and distributed globally. The Bilthoven Production Team is seeking a new member who embodies the innovative spirit of the company and is entrepreneurial in nature, aspiring to become a global leader in orthobiologics. This position will report to the Bilthoven office.

De Rol

The Process Development Engineer will provide daily technical support to manufacturing and operations, ensuring safe, compliant, and uninterrupted production of medical devices. This role acts as the primary engineering resource for troubleshooting equipment, process, and quality-related issues on the production floor. The successful candidate will collaborate closely with Production, Quality, Validation, Maintenance, Supply Chain, and R&D teams to identify root causes, implement corrective actions, minimize downtime, and drive continuous process improvements. This hands-on engineer thrives in a fast-paced GMP-regulated manufacturing environment, enjoys being on the production floor, and works effectively with operators and technicians to maintain efficient production. They balance technical rigor with practical decision-making and are committed to patient safety, product quality, and continuous improvement.

Verantwoordelijkheden

• Serve as the primary engineering contact for daily manufacturing issues.
• Investigate and resolve equipment, process, and product-related deviations.
• Provide real-time support to production personnel to minimize downtime and maintain production schedules.
• Perform root cause investigations using structured problem-solving methodologies (5-Why, Fishbone, DMAIC, etc.).
• Lead and document troubleshooting activities for manufacturing events and non-conformances.
• Support disposition activities and technical assessments related to production issues.

Vereisten

• HBO (BSc) / University (MSc.) in Biomedical Engineering / Medical Biology.
• 5+ years of experience in process development or manufacturing engineering, preferably in the medical device or pharmaceutical industry.
• Experience with IQ/OQ/PQ protocols and process validation.
• Previous experience in a GMP environment and/or ISO 13485 is preferred.
• Strong analytical and problem-solving skills.
• Excellent interpersonal and communication skills in English.
• Effective project planning, execution, and tracking to meet deadlines and budgets.
• Continuous improvement experience and project management skills.
• Ability to think creatively and develop innovative solutions.
• Comfortable working in a fast-paced, regulated environment.

Wat Wij Bieden

• A dynamic role with opportunities for growth and impact.
• Opportunities to innovate and shape processes.
• A supportive, collaborative work environment.
• Professional development and learning opportunities.

Kuros Biosciences offers a unique chance to join an international, innovative company with a diverse and energetic team. Contribute to the development of life-changing products while enjoying great benefits, a competitive salary, and opportunities for career advancement.