Research Engineer

Job Description

Research Engineer, Biological Safety and Orthopedic Devices

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Location: Remote, US-based

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

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

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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.

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Key responsibilities

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

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