Research Engineer

Mantu; Warsaw (IN); On-site; USD 110,000 - 160,000; Full time

Job summary

Mantu is seeking a Senior Research Engineer to lead and support research activities for orthopedic products in Indiana. The role involves planning studies, evaluating biocompatibility, and supporting regulatory submissions.

You will work across R&D, Clinical Affairs, Regulatory, Quality, Manufacturing, and external partners. The ideal candidate has a Master’s degree (PhD/DVM preferred), 5+ years in medical-device R&D with biological safety expertise, and proven leadership in cross-functional

Qualifications

• Master’s degree in a relevant scientific discipline; PhD or DVM preferred.
• 5+ years in medical-device R&D with biological safety risk assessments.
• 3–5 years neuroscience or preclinical research, incl. in vivo with large animals.
• Expertise in biological safety, ISO 10993, orthopedic device manufacturing, quality, and regulatory requirements.
• Strong project management, communication and leadership with cross-functional teams.

Responsibilities

• Identify, assess, and support development of orthopedic products through research planning and investigations.
• Develop and review study protocols, reports, biological evaluations, and safety risk assessments per ISO 10993.
• Coordinate lab and preclinical studies with internal teams, CROs, suppliers, and external partners.
• Conduct biocompatibility assessments and support biological safety testing strategies.
• Provide scientific/medical input for regulatory submissions, product development, and technical reviews.
• Collaborate with R&D, Design, Process Engineering, Manufacturing, Quality, Regulatory, Clinical, and Commercial teams.

Skills

Leadership

Project management

Scientific communication

Cross-functional collaboration

Public speaking

Education

Master’s degree in Neuroscience, Biomedical Science, Biology, Toxicology, or related field

PhD or DVM preferred

Job description

Senior Research Engineer, Orthopedic Products

Position summary

Our client is looking for a Senior Research Engineer to lead and support research activities related to orthopedic products.

The successful candidate will contribute to research planning, biological evaluation, preclinical studies, biocompatibility assessments, risk documentation, and regulatory activities. The role will act as a scientific resource for R&D, Clinical Affairs, Regulatory Affairs, Quality, Manufacturing, Marketing, Sales, and external research partners.

Main responsibilities

• Identify, assess, and support the development of new and existing orthopedic products through research planning and technical investigations.
• Develop, review, and approve study protocols, technical reports, biological evaluations, and biological safety risk assessments in accordance with ISO 10993.
• Coordinate laboratory and preclinical studies with internal teams, laboratories, CROs, suppliers, key opinion leaders, and external partners.
• Conduct biocompatibility assessments and support the development of biological safety testing strategies for new and sustaining products.
• Provide scientific and medical expertise for regulatory submissions, product development activities, technical reviews, and project presentations.
• Collaborate with R&D, Design, Process Engineering, Manufacturing, Quality, Regulatory, Clinical, and Commercial teams while supporting additional neuroscience-related research activities.

Qualifications

• Master’s degree in a relevant scientific discipline, such as Neuroscience, Biomedical Science, Biology, Toxicology, Materials Science, or a related field. A PhD or DVM is preferred.
• Typically, 5+ years of relevant industry experience with a Master’s degree, 3+ years with a PhD or DVM, or 10+ years with a Bachelor’s degree and directly relevant experience.
• 5+ years of experience in medical-device R&D with responsibility for biological safety risk assessments, or equivalent experience based on education and professional background.
• 3 to 5 years of research experience in neuroscience, tissue histology, or related preclinical research, including 3 to 5 years of hands‑on in vivo research with large animal models.
• Recognized expertise in biological safety, ISO 10993, orthopedic device manufacturing, quality, regulatory requirements, and regulated product development.
• Proven project management, problem‑solving, scientific communication, presentation, collaboration, and leadership skills, with the ability to communicate complex information to surgeons, management, regulatory bodies, key opinion leaders, and cross-functional teams.

Experience supporting successful regulated product development programs and working with external research partners is preferred. Travel of up to 20% may be required.