Lead Biomedical Safety Engineer – Orthopedic Devices

TekWissen LLC; Warsaw (IN); On-site; USD 120,000 - 180,000; Part time

Job summary

TekWissen Group seeks a Research Principal Engineer I to lead and support investigation and research activities for orthopedic products. You will drive study planning, execute biological evaluation, risk assessment, and regulatory documentation to support product development and regulatory objectives.

As a scientific liaison, you will collaborate across R&D, Regulatory Affairs, Marketing, and external partners, including laboratories and CROs, to advance research initiatives and ensure safety

Qualifications

• Master's degree in a relevant scientific discipline required; PhD or DVM preferred.
• Typically requires: Master's degree with 5+ years of industry experience, or PhD/DVM with 3+ years, or Bachelor's with 10+ years.
• 3-5 years of research experience in neuroscience, tissue histology, or related preclinical areas.
• 5+ years in medical device R&D with responsibility for biological safety risk assessment.
• Experience with successful project management is required.
• Experience supporting regulated product development and cross-functional research programs is preferred.

Responsibilities

• Lead or support investigation and research activities for orthopedic products.
• Develop strategy for technical investigations and provide scientific expertise to the team.
• Coordinate laboratory studies and associated deliverables.
• Conduct biocompatibility assessments and organize safety testing.
• Present scientific information to internal groups and regulatory bodies.
• Provide medical and scientific expertise to project teams as needed.

Skills

Biological safety ISO10993

Orthopedic device regulation

Scientific communication

Leadership

Project management

Cross-functional collaboration

Education

Master's degree in relevant science

PhD or DVM preferred

Bachelor's degree with relevant experience

Job description

TekWissen Group seeks a Research Principal Engineer I to lead and support investigation and research activities for orthopedic products. You will drive study planning, execute biological evaluation, risk assessment, and regulatory documentation to support product development and regulatory objectives.

As a scientific liaison, you will collaborate across R&D, Regulatory Affairs, Marketing, and external partners, including laboratories and CROs, to advance research initiatives and ensure safety