Remote Research Engineer, Biological Safety & Ortho Devices

Mantu; Denver (CO); Remote; USD 120,000 - 180,000; Full time

Job summary

Mantu in the United States seeks a Research Engineer to support investigation, research, and remediation for orthopedic medical devices. The role focuses on biological evaluation, preclinical work, risk assessment, documentation, and regulatory support across R&D, Design, Process, Manufacturing, Quality, Regulatory, and site teams.

You will lead protocols, safety studies, and cross‑functional risk management, coordinate labs and external collaborators, and contribute to regulatory submissions.

Qualifications

• Master’s degree in Biomedical Science, Biology, Toxicology, or related field.
• PhD or DVM preferred for advanced roles.
• 5+ years in medical-device R&D with biology safety risk assessment.
• 3–5 years preclinical in vivo research, including large-animal models.

Responsibilities

• Support remediation and lifecycle management of orthopedic products.
• Develop and review study protocols, reports, and safety documentation.
• Lead or support ISO 10993 based safety risk assessments.
• Coordinate investigations, timelines, and external collaborators.
• Support biocompatibility testing and safety assessments.
• Prepare regulatory submissions and scientific communications.
• Present data to internal and external stakeholders.

Skills

Biological safety

ISO 10993

Biocompatibility

Preclinical research

Project management

Technical writing

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Education

Master’s degree in Biomedical Science / related discipline

PhD or DVM preferred

Job description

Mantu in the United States seeks a Research Engineer to support investigation, research, and remediation for orthopedic medical devices. The role focuses on biological evaluation, preclinical work, risk assessment, documentation, and regulatory support across R&D, Design, Process, Manufacturing, Quality, Regulatory, and site teams.

You will lead protocols, safety studies, and cross‑functional risk management, coordinate labs and external collaborators, and contribute to regulatory submissions.