Senior Product Development Engineer

About Kuros Biosciences
Kuros Biosciences is a Swiss-listed life science company specializing in orthobiologics for spinal fusion surgery. With locations in Switzerland, the USA, and the Netherlands, we manufacture our bone repair products in Bilthoven and sell them worldwide. We are seeking an experienced Senior Product Development Engineer to join our growing team in Bilthoven.

Position Overview

The Sr. Product Development Engineer is responsible for leading the development of bone void filler and orthobiologics products from concept through design transfer and commercial launch. The role combines hands-on product development engineering with biomaterials expertise, including formulation, characterization, and performance of materials such as ceramics, polymers, and composites. The role responsibilities include, but are not limited to:

• Lead cross-functional Project Teams through all phases of Design and Development


• Leadership to conduct multiple experiments and translation into regulatory compliance


• Coordination and report on technical deliverables through all Design & Development phases


• Own and maintain Design History Files (DHF) in compliance with regulatory and internal requirements


• Define design inputs/outputs and ensure traceability throughout development


• Drive verification & validation (V&V) activities, including protocol development and execution


• Lead design transfer to manufacturing, ensuring scalability and robustness


• Identification and coordination of vendors, e.g. materials, contract manufacturing


• Creation and management of project timelines, milestones, and budget

Responsibilities

Technical:

• Expertise in biomaterials formulation development & characterization, experimental design and data analysis


• Expertise in verification & validation strategies, design transfer and manufacturing processes


• Develop and manage project timelines, milestones, budgets, and deliverables


• Coordinate internal and external stakeholders, including vendors, CROs and CDMOs


• Stay up to date with technologies in bone replacement materials and share knowledge across teams


• Manage and support other team members and foster a collaborative environment


• Collaborate closely with Research, Quality, Regulatory, Commercial and Manufacturing teams to ensure alignment between product performance, safety, regulatory, and manufacturability requirements


• Identify risks and implement mitigation strategies


• Contribute to scientific writing, including patents, technical reports, and publications


• Support generation of data for internal decision-making and external communication

Quality, Regulatory & Risk Management

• Ensure compliance with design control processes, quality system ISO 13485, and applicable regulatory requirements


• Knowledge and application of Design and Development Procedures


• Contribute to risk management activities (ISO 14971)


• Prepare and review documentation supporting regulatory submissions (e.g., 510(k), technical files)


• Develop and review SOPs, test methods, and development procedures


• Ensure all development work is properly documented and inspection-ready

Safety/Organizational/Productivity

• Know, understand, and adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents, and radioactive hazards


• Participate in the introduction and evaluation of new procedures, supplies and equipment


• Ensure proper training of colleagues, students, etc.


• Use resources (equipment, disposables, time) in a responsible, cost-effective manner

Qualifications

Education:
MSc in (bio)material science, biomedical engineering, Chemistry or related field

Experience:

• 5+ years of experience in medical device or combination product development


• Demonstrated experience in project and team leadership


• Strong background in biomaterials development (bone grafts, ceramics, polymers preferred)


• Experience with design control and DHF ownership


• Experience working with external partners and vendors

Skills

• Curious, doer, self-starter and hands-on, with a strong sense of ownership


• Must be able to work well independently, as well as being able to work cooperatively in a team of professionals


• Effective communicator and team collaborator


• Strong and efficient interpersonal skills are necessary


• Strong problem-solving and critical thinking skills, with the ability to translate scientific concepts into practical product solutions

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.