Research Principal Engineer I

Aequor; Warsaw (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Aequor is seeking a senior scientific leader to drive investigation and research for orthopedic products. You will plan studies, support regulatory documentation, and provide expert biological safety assessments across the portfolio.

You will collaborate with R&D, Regulatory, Clinical, and Marketing teams, mentor scientists, and engage with external experts and labs to advance product development and neuro-related research needs.

Qualifications

• Master’s degree required; PhD or DVM preferred.
• Typically requires: Master’s with 5+ years of relevant industry experience, or PhD or DVM with 3+ 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.

Responsibilities

• Identify, assess, and support development of orthopedic products.
• Lead or support development and approval of technical documentation per ISO 10993.
• Develop strategy for technical investigations and provide scientific expertise.
• Contribute biological safety content for regulatory submissions.
• Serve as SME for biological evaluation across product portfolio.
• Coordinate and track laboratory studies and deliverables.
• Conduct biocompatibility assessments and organize safety testing.
• Present scientific information to internal and external stakeholders.
• Provide medical and scientific expertise to project teams and marketing.
• Develop materials for project updates and data presentations.
• Support interactions with key opinion leaders and external collaborators.

Skills

Biological safety ISO 10993

Orthopedic device regulatory

Scientific data presentation

Cross-functional collaboration

Project leadership

Communication

KOL engagement

Education

Master’s degree in a relevant scientific discipline

PhD or DVM preferred

5+ years relevant industry experience

3-5 years neuroscience/preclinical research

5+ years medical device R&D with biological safety risk assessment

Bachelor’s degree with 10+ years relevant experience

Job description

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.