Research Engineer

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

Research Engineer, Biological Safety and Orthopedic Devices

Location: Remote, US-based

Preferred location: Denver, CO, with onsite work possible for local candidates

We are looking for a Research Engineer to support investigation, research, and remediation activities for orthopedic medical devices.

This role will focus on biological evaluation, preclinical research, risk assessment, technical documentation, and regulatory support. The successful candidate will work closely with R&D, Design Engineering, Process Engineering, Manufacturing, Quality, Regulatory Affairs, Corporate, and site teams.

Key responsibilities

• Support the remediation and lifecycle management of existing orthopedic products.
• Develop, review, and approve study protocols, technical reports, and biological safety documentation.
• Lead or support biological safety risk assessments in accordance with ISO 10993.
• Develop strategies for technical investigations and provide scientific expertise to cross‑functional teams.
• Coordinate laboratory studies, preclinical testing, timelines, deliverables, and external collaborators.
• Support biocompatibility assessments and biological safety testing.
• Contribute biological safety content and technical rationale for regulatory submissions.
• Present scientific and technical information to internal stakeholders, regulatory bodies, surgeons, key opinion leaders, and external experts.
• Prepare project updates, technical reviews, data presentations, and research summaries.
• Support cross‑functional project planning, risk management, scope, timelines, and execution.

Required qualifications

• Master’s degree in Biomedical Science, Biology, Toxicology, Materials Science, or a related discipline.
• PhD or DVM is preferred.
• 5+ years of experience in medical-device R&D with responsibility for biological safety risk assessment, or equivalent experience.
• 3 to 5 years of hands‑on preclinical in vivo research, including large‑animal model testing.
• Strong knowledge of ISO 10993, biocompatibility, biological evaluation, and orthopedic‑device requirements.
• Experience supporting regulated product development and cross‑functional research programs..
• Demonstrated project‑management experience.
• Strong scientific writing, presentation, problem-solving, and stakeholder-management skills.
• Ability to communicate complex scientific and regulatory topics clearly to technical and non-technical audiences.

This opportunity is ideal for someone with strong expertise in biological safety, orthopedic devices, preclinical research, and regulated medical-device development.