Principal Research Engineer 7602

Mainz Brady Group; Denver (CO); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Mainz Brady Group is seeking a Senior Research Scientist to lead biological safety and biocompatibility investigations for orthopedic medical devices. The role emphasizes ISO 10993 compliance, preclinical in vivo research, and cross-functional collaboration with engineering, regulatory, and quality teams.

The ideal candidate brings hands-on preclinical experience, strong regulatory knowledge, and excellent scientific communication to drive safety evaluations and regulatory readiness across

Competenze

• Master's degree with 5+ years of relevant experience or PhD/DVM with 3+ years preferred.
• Experience with ISO10993 biological evaluation and biocompatibility.
• Demonstrated ability to develop, review, and interpret biological safety risk assessments and technical documentation.
• Proven project management experience in regulated medical device settings.
• Excellent scientific writing, analytical, problem-solving, and presentation skills.

Mansioni

• Lead and support investigations, research initiatives, and remediation activities for orthopedic devices.
• Develop, review, and approve protocols, reports, and biological safety risk assessments per ISO 10993.
• Design and support preclinical studies including in vivo testing and large animal models.
• Develop biological evaluation plans and testing strategies for safety and regulatory compliance.
• Coordinate biological safety testing with internal teams and external labs.
• Provide scientific and technical guidance for investigations, risk assessments, and remediation initiatives.
• Prepare biological safety documentation for regulatory submissions.
• Analyze and present preclinical and biological data to stakeholders.
• Collaborate with design, process engineering, manufacturing, quality, regulatory, and research teams.
• Serve as SME in biological safety and orthopedic device research.
• Manage research activities, timelines, and lab studies.
• Engage with external researchers and key opinion leaders.
• Present findings to leadership, regulatory stakeholders, and scientific audiences.

Conoscenze

Biological safety

Biocompatibility

ISO 10993

Regulatory knowledge

Preclinical in vivo research

Project management

Scientific writing

Cross-functional collaboration

Medical device R&D

Data interpretation

Formazione

Master's degree in Biomedical Science/ Biology/ Toxicology/ Materials Science/ Biomedical Engineering

PhD or DVM preferred

Bachelor's with significant directly relevant experience

Descrizione del lavoro

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

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 ISO10993 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 ISO10993, 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.