Senior Research Scientist – Biological Safety & Biocompatibility (Orthopedic Medical Devices)

Industry: Medical Devices | Orthopedics | Research & Development

Position Summary

We are seeking an experienced Senior Research Scientist – Biological Safety & Biocompatibility to lead and support scientific investigations, preclinical research, biological evaluations, and product remediation activities for orthopedic medical devices.

This position requires strong expertise in ISO 10993, biological safety risk assessments, preclinical in vivo research, and medical device R&D. The ideal candidate will bring a combination of hands-on scientific research, technical leadership, and regulatory knowledge to support product safety, compliance, and continuous improvement.

The successful candidate will collaborate with engineering, manufacturing, quality, regulatory, and research teams while providing scientific expertise and technical guidance throughout the product lifecycle.

Key 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.

Required Qualifications

• Master’s degree in Biomedical Science, Biology, Toxicology, Materials Science, Biomedical Engineering, or a related scientific discipline. PhD or DVM preferred.

• Bachelor’s degree with significant directly relevant experience may be considered.

• 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.

• Proven project management experience.

• Strong understanding of medical device regulatory, quality, and manufacturing requirements.

• Excellent scientific writing, analytical, problem-solving, and presentation skills.

• Ability to independently lead technical investigations and collaborate across multidisciplinary teams.

Preferred Qualifications

• Experience with orthopedic implants, surgical devices, or other implantable medical technologies.

• Experience supporting product remediation, sustaining engineering, or post-market biological safety evaluations.

• Experience preparing scientific documentation and technical justifications for regulatory submissions.

• Demonstrated success leading cross-functional research programs in a regulated medical device environment.

• Experience presenting scientific or preclinical research findings to surgeons, regulatory stakeholders, and external scientific experts.

• Strong knowledge of biological evaluation strategies, risk management, and preclinical study design.

Ideal Candidate

The ideal candidate is an experienced biological safety scientist or medical device research professional with a strong foundation in ISO 10993, hands-on preclinical research, and orthopedic device development.

This individual can independently evaluate complex scientific and biological safety challenges, develop defensible technical strategies, and communicate findings effectively to engineering, regulatory, and scientific stakeholders.