Senior Biocompatibility Engineer – Orthopedics R&D (Remote)

TekWissen ®; Englewood (CO); Remote; USD 85,000 - 90,000; Full time

Job summary

TekWissen is seeking a Senior Biocompatibility Engineer in Englewood, CO for a 12-month temporary assignment with remote work options. The role focuses on supporting investigation and research for orthopedic products, including biocompatibility, safety risk assessments, and regulatory objectives.

You will collaborate across design, process engineering, manufacturing, quality, regulatory, and sites. The ideal candidate has a strong foundation in ISO 10993, orthopedic device manufacturing, and

Qualifications

• Bachelor’s degree in a relevant scientific discipline required; Master’s preferred.
• Typically requires Master’s with 3+ years of relevant industry experience, or Bachelor’s with 5+ years.
• 3+ years in medical device R&D with biological safety risk assessment.

Responsibilities

• Identify, assess, and support remediation of existing orthopedic products.
• Develop, review, and approve technical documentation including study protocols and biological safety risk assessments per ISO 10993.
• Conduct biocompatibility assessments and organize required testing.
• Present scientific data to internal groups and stakeholders.

Skills

Biological safety (ISO 10993)

Orthopedic device knowledge

Regulatory knowledge

Scientific communication

Cross-functional collaboration

Education

Bachelor's degree in biomedical sciences or related field

Master's degree preferred

Job description

TekWissen is seeking a Senior Biocompatibility Engineer in Englewood, CO for a 12-month temporary assignment with remote work options. The role focuses on supporting investigation and research for orthopedic products, including biocompatibility, safety risk assessments, and regulatory objectives.

You will collaborate across design, process engineering, manufacturing, quality, regulatory, and sites. The ideal candidate has a strong foundation in ISO 10993, orthopedic device manufacturing, and