RCI-ZB-37606640 Research Principal Engineer

Job Summary

• Responsible for leading and supporting investigation and research activities for orthopedic products.
• This role drives research planning, study execution support, and outcome tracking, biological evaluation, and risk assessment documentation to support product development and regulatory objectives.
• Serves as a scientific subject matter expert and advisor to cross-functional teams including R&D, Marketing, Sales, Clinical Affairs, and Regulatory Affairs.
• Acts as a key scientific liaison with external key opinion leaders, laboratories, suppliers, CROs and partner organizations.
• Collaborates across design, process engineering, manufacturing, quality, regulatory, corporate, and site teams to advance research initiatives and support broader neuro-related project needs.

Principal Duties and Responsibilities:

• Identify, assess, and support the development of new and existing orthopedic products
• Lead or support development, review, and approval of technical documentation, including study protocols, reports, and biological safety risk assessments per ISO 10993.
• Develop strategy for technical investigations and provide scientific expertise to the research team and other 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, track laboratory studies and associated deliverables.
• Conduct biocompatibility assessments and organize required biological safety testing.
• Support 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, as needed.
• 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.
• This is not intended to be an exhaustive list of duties and may not include all essential functions of the role.

Skills:

Expected Areas of Competence (i.e., knowledge, skills and abilities)

• Recognized subject matter expertise in biological safety (ISO 10993) and orthopedic device manufacturing/quality/regulatory requirements.
• Strong foundation of internal and external training in area of biological safety.
• Demonstrated ability to present preclinical and scientific data clearly, credibly, and persuasively to expert audiences and key opinion leaders.
• Ability to communicate complex scientific concepts in a clear, concise, and audience appropriate manner.
• Strong and independent problem-solving skills, including the ability to evaluate complex situations, identify practical solutions, and execute effectively in a timely manner.
• Demonstrated ability to expand current knowledge, methods, and procedures and establish approaches that others can build upon.
• Ability to balance cross-functional priorities to meet customer expectations and project timelines.
• Effective use of resources, sound judgment, and strong execution skills.
• Demonstrated professionalism and ability to represent the company effectively, including in challenging or conflicting situations.
• Strong negotiation and collaboration skills related to scope, design, process, and timelines.
• Strong written, verbal, and presentation skills, with the ability to respond confidently to scientific and regulatory questions.
• Ability to discuss complex topics with confidence and credibility.
• Ability to communicate sensitive or complex information effectively with management, surgeons, external experts, and other stakeholders.
• Demonstrated leadership, initiative, and accountability.

Education:

Education/Experience Requirements

• Master’s degree in a relevant scientific discipline required; PhD or DVM preferred.
• Relevant disciplines may include neuroscience, biomedical science, biology, toxicology, materials science, or a related field.
• ? Bachelor’s degree with significant directly relevant experience may be considered in lieu of an advanced degree.
• ? Typically requires: Master’s degree with 5 years of relevant industry experience, or PhD or DVM with 3 years of relevant industry experience, or Bachelor’s degree with 10 years of relevant experience.
• ? 3-5 years of research experience in neuroscience, tissue histology, or related preclinical research areas.
• ? 3-5 years of hands-on experience in preclinical in vivo research, including large animal model testing.
• ? 5 years of experience in medical device R&D with responsibility for biological safety risk assessment, or equivalent depth of experience based on degree level.
• ? Experience with successful project management is required.
• ? Experience supporting regulated product development and cross-functional research programs is preferred.

Travel Requirements

• Up to 20%

Career link: https://talentarbor.com/job/details/140833/3/560/research-principal-engineer-warsaw-in-us