Senior Biocompatibility Scientist - Orthopedic Medical Devices

Mainz Brady Group; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Mainz Brady Group is seeking a Senior Research Scientist - Biological Safety & Biocompatibility to lead investigations and preclinical studies for orthopedic medical devices. You will apply ISO 10993 principles, manage biological safety risk assessments, and guide remediation activities throughout the product lifecycle.

The ideal candidate combines hands-on research with regulatory know-how, collaborates with engineering, quality, and regulatory teams, and communicates complex data to leadership

Qualifications

• Master's degree or higher in Biomedical Science, Biology, Toxicology, or related field; PhD/DVM preferred.
• 5+ years of relevant experience for Master's path; 3+ years for PhD/DVM; 10+ years for BS path.
• 3-5 years hands-on preclinical in vivo research, including large animal models.
• 5+ years of medical device R&D involving biological safety risk assessments.
• Expertise in ISO 10993 biological evaluation and biocompatibility requirements.
• Experience developing and interpreting biological safety risk assessments and technical docs.
• Strong regulatory, quality, and manufacturing understanding.
• Excellent scientific writing, analytical, problem-solving, and presentation skills.
• Ability to independently lead investigations and collaborate across multidisciplinary teams.

Responsibilities

• Lead investigations, research initiatives, and remediation for orthopedic devices.
• Develop, review, and approve study protocols, reports, biological evaluations, and risk assessments per ISO 10993.
• Design preclinical studies, including in vivo testing and large animal models.
• Develop biological evaluation plans, testing strategies, and scientific justifications for safety and regulatory needs.
• Coordinate biological safety testing with internal teams and external laboratories.
• Provide scientific and technical expertise for investigations and product remediation initiatives.
• Prepare biological safety documentation and rationale for regulatory submissions.
• Analyze, interpret, and present preclinical and biological data to stakeholders.
• Collaborate with design engineering, process engineering, manufacturing, quality, regulatory, and research teams.
• Serve as SME in biological safety, biocompatibility, and orthopedic device research.
• Manage research activities, laboratory studies, project deliverables, and timelines.
• Develop relationships with external researchers and key opinion leaders.
• Present findings and recommendations to leadership and regulatory audiences.

Skills

Scientific writing

Analytical thinking

Presentation skills

Independent investigations

Education

Master's degree in Biomedical Science or related

PhD or DVM preferred

Bachelor's degree with significant relevant experience

Tools

ISO 10993 biological evaluation

Biocompatibility testing

Regulatory documentation preparation

Job description

Mainz Brady Group is seeking a Senior Research Scientist - Biological Safety & Biocompatibility to lead investigations and preclinical studies for orthopedic medical devices. You will apply ISO 10993 principles, manage biological safety risk assessments, and guide remediation activities throughout the product lifecycle.

The ideal candidate combines hands-on research with regulatory know-how, collaborates with engineering, quality, and regulatory teams, and communicates complex data to leadership