Biological Safety / Biocompatibility Engineer – Orthopedic Medical Devices

Position Summary

We are seeking an experienced Biological Safety / Biocompatibility Engineer to support research, investigation, and remediation activities for orthopedic medical devices. This role focuses on biological safety evaluations, biocompatibility testing, risk assessments, and technical documentation in accordance with ISO 10993 and applicable regulatory requirements.

The ideal candidate will have a strong background in medical device R&D, biological safety risk assessment, and cross-functional collaboration. This individual will work closely with engineering, manufacturing, quality, regulatory, and research teams to support product remediation initiatives and regulatory compliance objectives.

Key Responsibilities

• Support investigations, research activities, and remediation efforts for existing orthopedic medical devices.

• Develop, review, and approve technical documentation, including study protocols, technical reports, and biological safety risk assessments in accordance with ISO 10993.

• Conduct biocompatibility assessments and coordinate biological safety testing activities.

• Develop testing strategies and biological evaluation plans to support product safety and regulatory requirements.

• Prepare biological safety documentation, technical justifications, and supporting scientific rationale.

• Collaborate with design engineering, process engineering, manufacturing, quality, regulatory, and site teams to achieve project objectives.

• Analyze and present scientific, preclinical, and technical data to internal stakeholders.

• Prepare project updates, technical review materials, and presentations to communicate findings and recommendations.

• Support risk assessments, product remediation initiatives, and regulatory documentation activities.

• Manage competing priorities and project timelines while maintaining quality and compliance standards.

Required Qualifications

• Bachelor’s degree in Biomedical Science, Biology, Toxicology, Materials Science, Biomedical Engineering, or a related scientific discipline.

• Master’s degree preferred.

• Master’s degree with 3+ years of relevant industry experience or bachelor’s degree with 5+ years of relevant experience.

• Minimum 3 years of medical device R&D experience involving biological safety risk assessments, or equivalent experience based on education