Biocompatibility Engineer
Core
Systems Engineering and biocompatibility expert for Brachytherapy applicators, ensuring medical devices meet safety, quality, and regulatory standards for cancer treatment.
Role type
Senior Systems Engineer (Biocompatibility)
Builds
Brachytherapy applicators and medical devices for cancer treatment
Domain
Medical devices / Oncology / Radiation therapy
Required skills
Systems engineering, Biocompatibility, Materials science, Risk management, Regulatory compliance (ISO 13485, ISO 14971, ISO 10993), Sterilization and reprocessing, Design controls, Root cause analysis, Laboratory testing coordination
Preferred skills
Dutch language skills, Agile/SAFe framework experience, Mechanical engineering background
Technologies
ISO 10993, ISO 13485, ISO 14971, IEC 60601, EU MDR, FTIR, Gas chromatography, BET/LAL testing
Responsibilities
Translate clinical needs into engineering requirements; Define and maintain system architectures and documentation; Drive systems engineering activities (requirements, traceability, risk, verification); Act as SME for biocompatibility and biological safety; Coordinate external laboratory testing; Support root cause analysis and improvement proposals; Define work packages and timelines; Provide technical coaching to engineering teams.
Seniority
Senior, hands-on IC