Senior Product Development Engineer

Location: Bilthoven

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.

Lead cross‑functional project teams through all phases of design and development

Leadership to conduct multiple experiments and translate into regulatory compliance

Coordinate and report on technical deliverables through all design and 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

We offer great benefits, a competitive salary, and opportunities for career growth.

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