Senior Biocompatibility Research Engineer – On-Site Warsaw

Swoon; Warsaw (IN); On-site; USD 117,000 - 131,000; Full time

Job summary

Swoon is seeking a Research Principal Engineer I for a senior R&D role in Warsaw, Indiana, focusing on biological safety, biocompatibility, ISO 10993, and preclinical research for orthopedic medical devices. On-site, 12-month contract with travel up to 20%.

The role requires 3–5+ years of preclinical experience, hands-on in vivo and large animal study experience, and strong cross-functional collaboration to support regulatory submissions.

Qualifications

• Minimum 5+ years of preclinical research in medical device R&D.
• Strong experience with ISO 10993 and biocompatibility.
• Experience writing study protocols and scientific reports.

Responsibilities

• Lead and support research activities for medical devices.
• Develop and review biological safety and biocompatibility strategies.
• Prepare biological safety risk assessments in accordance with ISO 10993.
• Develop, review, and approve study protocols and technical reports.
• Coordinate laboratory and preclinical studies.
• Support in vivo research and large animal model testing.
• Evaluate biological and preclinical study results.
• Provide documentation for regulatory submissions.
• Partner with R&D, Quality, Regulatory, Clinical, Manufacturing and external partners.
• Work with CROs, laboratories, suppliers, surgeons and key opinion leaders.
• Present findings to internal and external stakeholders.

Skills

Biological safety

Biocompatibility

Preclinical research

In vivo studies

Project management

Cross-functional leadership

Regulatory documentation

Scientific communication

Education

Master’s degree +5 years

PhD/DVM +3 years

Bachelor’s +10 years

Job description

Swoon is seeking a Research Principal Engineer I for a senior R&D role in Warsaw, Indiana, focusing on biological safety, biocompatibility, ISO 10993, and preclinical research for orthopedic medical devices. On-site, 12-month contract with travel up to 20%.

The role requires 3–5+ years of preclinical experience, hands-on in vivo and large animal study experience, and strong cross-functional collaboration to support regulatory submissions.