Research Principal Engineer I

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

Research Principal Engineer I – Medical Device R&D

Location: Warsaw, IN – On-site

Duration: 12-month contract

Pay: $85–$95/hr

Travel: Up to 20%

Client: Confidential

I’m hiring a Research Principal Engineer I for a leading medical device organization in Warsaw, Indiana.

This is a senior-level R&D role focused on biological safety, biocompatibility, ISO 10993, and preclinical research supporting orthopedic medical devices.

Key Responsibilities:

• Lead and support research activities for new and existing 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 scientific rationale and technical documentation for regulatory submissions
• Partner cross-functionally with R&D, Quality, Regulatory, Clinical, Manufacturing, and external research partners
• Work with CROs, laboratories, suppliers, surgeons, and key opinion leaders
• Present scientific and technical findings to internal and external stakeholders

What We’re Looking For:

• Strong experience with ISO 10993, biological safety, and biocompatibility
• Experience with biological evaluation and biological safety risk assessments
• Medical device R&D experience, preferably with orthopedic or implantable devices
• 3–5+ years of preclinical research experience
• Hands‑on in vivo and large animal study experience
• Experience writing study protocols, technical reports, and scientific documentation
• Strong project management, communication, and cross-functional leadership skills

Education:

• Master’s degree with 5+ years of relevant experience, or
• PhD/DVM with 3+ years of relevant experience, or
• Bachelor’s degree with 10+ years of directly relevant experience

Relevant backgrounds may include Biomedical Science, Biology, Toxicology, Materials Science, Neuroscience, or a related discipline.

Candidates must be able to work on-site in Warsaw, Indiana.

If your background includes medical device R&D, ISO 10993, biocompatibility, biological safety, and preclinical research, I’d be interested in connecting.