Senior Orthopedic Research Engineer — Biocompatibility & Preclinical

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

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