About This Role
This senior research scientist role focuses on biological safety and biocompatibility for orthopedic medical devices. It involves leading scientific investigations, preclinical research, biological evaluations, and product remediation. The position suits a candidate with strong expertise in ISO 10993, biological safety risk assessments, preclinical in vivo research, and medical device R&D.
Responsibilities
- Lead and support scientific investigations, research initiatives, and remediation activities for existing orthopedic medical devices
- Develop, review, and approve study protocols, technical reports, biological evaluations, and biological safety risk assessments in accordance with ISO 10993
- Design and support preclinical research studies, including in vivo testing and large animal models
- Develop biological evaluation plans, testing strategies, and scientific justifications to support product safety and regulatory requirements
- Conduct biocompatibility assessments and coordinate biological safety testing with internal teams and external laboratories
- Provide scientific and technical expertise for investigations, risk assessments, and product remediation initiatives
- Prepare biological safety documentation and supporting scientific rationale for regulatory submissions
- Analyze, interpret, and present preclinical, biological, and technical data to internal and external stakeholders
- Collaborate with design engineering, process engineering, manufacturing, quality, regulatory, and research teams
- Serve as a subject matter expert in biological safety, biocompatibility, and orthopedic device research
- Manage research activities, laboratory studies, project deliverables, and timelines
- Develop and maintain relationships with external researchers, scientific collaborators, and key opinion leaders
- Present technical findings and recommendations to leadership, regulatory stakeholders, and scientific audiences
Requirements
- Master's degree in Biomedical Science, Biology, Toxicology, Materials Science, Biomedical Engineering, or a related scientific discipline
- Relevant industry experience:
- Master's degree with 5+ years of experience
- PhD or DVM with 3+ years of experience
- Bachelor's degree with 10+ years of experience
- 3–5 years of hands-on preclinical in vivo research experience, including large animal model testing
- 5+ years of medical device R&D experience involving biological safety risk assessments, or equivalent experience based on education
- Demonstrated expertise in ISO 10993 biological evaluation and biocompatibility requirements
- Experience developing, reviewing, and interpreting biological safety risk assessments and technical documentation
