Job#: 3057002 Job Description: Research Principal Engineer I
Location: Warsaw, Indiana (On-site)
Role Overview
This position is responsible for leading and supporting investigation and research activities for orthopedic products. The selected candidate will drive research planning, study execution support, outcome tracking, biological evaluation, and risk assessment documentation to support product development and regulatory objectives. Acting as a scientific subject matter expert, this professional will advise cross-functional teams and serve as a key scientific liaison with external partners, laboratories, suppliers, and academic collaborators.
Key Responsibilities
- Identify, assess, and support the development of new and existing orthopedic products.
- Lead and support the development, review, and approval of technical documentation, including study protocols, reports, and biological safety risk assessments per ISO 10993.
- Develop strategies for technical investigations and provide scientific expertise to the research team and cross-functional partners.
- Contribute biological safety content and supporting rationale for regulatory submissions and related technical documents.
- Serve as a subject matter resource for biological evaluation activities related to new product development and sustaining products across the portfolio.
- Coordinate, initiate, and track laboratory studies and associated deliverables.
- Conduct biocompatibility assessments and organize required biological safety testing.
- Support the development of testing strategies and biological safety risk assessments for orthopedic products.
- Present scientific and technical information to internal groups, stakeholders, and regulatory bodies as necessary.
- Provide medical and scientific expertise to project teams, marketing, global sales, and medical information functions.
- Develop materials for project updates, technical reviews, and data presentations.
- Support relationships and scientific interactions with key opinion leaders and external collaborators.
- Contribute to additional neuro-related research activities based on business and project needs.
Required Qualifications
Education: A Master's degree in a relevant scientific discipline such as neuroscience, biomedical science, biology, toxicology, materials science, or a related field is required. A PhD or DVM is preferred. A Bachelor's degree with significant directly relevant experience may be considered in lieu of an advanced degree.
Experience: Candidates must possess appropriate industry experience relative to their degree level, typically requiring a Master's degree with 5 or more years of industry experience, a PhD or DVM with 3 or more years of industry experience, or a Bachelor's degree with 10 or more years of experience. Additionally, the role requires 3 to 5 years of research experience in neuroscience, tissue histology, or related preclinical research, alongside 3 to 5 years of hands-on experience in preclinical in vivo research, including large animal model testing. At least 5 years of experience in medical device research and development with responsibility for biological safety risk assessment is required. Demonstrated experience in successful project management is also necessary.
Technical Skills: Recognized subject matter expertise in biological safety standards (ISO 10993) and orthopedic device manufacturing, quality, and regulatory requirements is essential. Strong written, verbal, and presentation skills are required to communicate complex scientific concepts clearly and persuasively to expert audiences, regulatory bodies, and external collaborators.
Preferred Qualifications
- Experience supporting regulated product development and cross-functional research programs.
- Advanced training in preclinical research methodologies and biological safety frameworks.
Work Environment
This position requires the ability to travel up to 20% to support collaborations, laboratory studies, and project objectives.
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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