Process Development Engineer

Posted 20 Days Ago
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Bilthoven, NLD
In-Office
Senior level
Biotech
The Role
Provide hands-on engineering support for GMP medical device manufacturing: troubleshoot equipment and process issues, lead root-cause investigations, implement corrective actions, support dispositions, and drive continuous process improvements alongside cross-functional teams.
Summary Generated by Built In

Process Development Engineer


Kuros Biosciences is a Swiss-listed life science company with offices in Bilthoven (The Netherlands), Atlanta (USA) and Schlieren (Switzerland). Kuros focuses on the development and marketing of orthobiologics for spinal fusion surgery, a procedure used to stabilize the spine in patients with back problems. The Kuros bone repair products are developed and manufactured in Bilthoven and sold worldwide. The Kuros Bilthoven Production Team is looking for a new team member that fits the spirit of an innovative company and entrepreneurial aiming to become the global leader in orthobiologics. This position will report to the Bilthoven office.



Position Summary

The Manufacturing Support Engineer is responsible for providing day-to-day technical support to manufacturing/operations to ensure the safe, compliant, and uninterrupted production of medical devices. This role serves as the primary engineering resource for troubleshooting equipment, process, and quality-related issues on the production floor. The successful candidate will work 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. The role requires a hands-on engineer who thrives in a fast-paced GMP-regulated manufacturing environment. The ideal candidate is a highly visible, hands-on engineer who enjoys being on the manufacturing floor, solving problems quickly, and working with operators and technicians to keep production running efficiently. They balance technical rigor with practical decision-making and have a strong commitment to patient safety, product quality, and continuous improvement.


Key Responsibilities

Production Support & Troubleshooting

  • 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.

 


Skills

The successful candidate will be:

  • Able to work well independently, as well as being able to work cooperatively in a team of professionals and cross functionally
  • Excellent interpersonal and people leadership skills
  • Good knowledge of English language required
  • Excellent communication skills to collaborate with cross-functional team, internal and external parties, present findings and document processes
  • Strong Analytical skills and problem-solving skills
  • Effective project planning, execution and tracking to meet deadlines and budgets
  • Continuous improvement experience and project management skills. Ability to design and improve manufacturing processes.
  • The ability to think creatively and come up with innovative solutions
  • Collaborating effectively with colleagues including operators, technicians and other engineers
  • Comfortable working in a fast-paced, regulated environment


Education and/ or Experience

  • HBO (BSc) / University (MSc.) in the field of 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 with working in a GMP environment and/or ISO 13485 is preferred

 

What We Offer

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



Our credentials:

With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOs™, is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visit kurosbio.com.

  • Listing on the SIX Swiss Exchange under the symbol KURN
  • A commercial & research footprint that spans >20 markets
  • 4 teams of internationally renowned clinical and scientific expert advisers
  • >25 orthobiologics-related patents
  • >400 patients evaluated in Level I, randomized controlled clinical trials
  • >20 well-controlled Level I-III clinical trials initiated, including 6 that are complete
  • Level I evidence published in Spine


Why Kuros Biosciences?

Join an international, innovative company with a diverse and energetic team. At Kuros, you’ll work in a positive and collaborative environment, contributing to the development of life-changing products. We offer great benefits, a competitive salary, and opportunities for career growth.

 

 

Skills Required

  • BSc (HBO) or MSc in Biomedical Engineering or Medical Biology
  • 5+ years experience in process development or manufacturing engineering (medical device or pharmaceutical preferred)
  • Experience with IQ/OQ/PQ protocols and process validation
  • Previous experience working in a GMP environment and/or familiarity with ISO 13485
  • Strong analytical and structured problem-solving skills (5-Why, Fishbone, DMAIC)
  • Excellent communication, interpersonal and cross-functional collaboration skills
  • Ability to work independently and in teams; hands-on on the manufacturing floor
  • Continuous improvement experience and project management skills
  • Good knowledge of English
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The Company
HQ: Schlieren
119 Employees

What We Do

OUR PURPOSE Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies. OUR CREDENTIALS Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016. With additional operations in the Netherlands and the USA, we continue to grow our global team. To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to advance bone healing. Kuros is an innovative global company with: - Listing on the SIX Swiss Exchange under the symbol KURN - A commercial & research footprint that spans >20 markets - 4 teams of internationally renowned clinical and scientific expert advisers - >25 orthobiologics-related patents - >400 patients evaluated in Level I, randomized controlled clinical trials - 10 well-controlled Level I-III clinical trials initiated, including 6 that are complete CONTACT KUROS TO FIND OUT MORE >>>>

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