Biocompatibility Engineer for Orthopedic Medical Devices

Mainz Brady Group; Denver (CO); On-site; USD 110,000 - 150,000; Full time

Job summary

Mainz Brady Group in Denver, CO is seeking an experienced Biological Safety / Biocompatibility Engineer to support investigations, remediation, and regulatory compliance for orthopedic medical devices. The role emphasizes ISO 10993 biocompatibility strategies, risk assessments, and cross-functional collaboration with engineering, manufacturing, quality and regulatory teams.

The ideal candidate will bring a strong background in medical device R&D, biological safety risk assessment, and the

Qualifications

• Bachelor's degree in Biomedical Science, Biology, Toxicology, Materials Science, Biomedical Engineering, or related field.
• 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.

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.

Skills

Biocompatibility testing

ISO 10993

Biomedical R&D

Risk assessment

Education

Bachelor's degree in Biomedical Science/ Biology/ Toxicology/ Materials Science/ Biomedical Engineering

Master's degree preferred

Job description

Mainz Brady Group in Denver, CO is seeking an experienced Biological Safety / Biocompatibility Engineer to support investigations, remediation, and regulatory compliance for orthopedic medical devices. The role emphasizes ISO 10993 biocompatibility strategies, risk assessments, and cross-functional collaboration with engineering, manufacturing, quality and regulatory teams.

The ideal candidate will bring a strong background in medical device R&D, biological safety risk assessment, and the