Biocompatibility Engineer II: Reprocessing & Regulatory Focus

Teleflex; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Teleflex seeks a Biocompatibility Engineer II to join our Global Biocompatibility department in Morrisville, NC. You will independently develop biocompatibility and reprocessing assessments and manage testing activities to support R&D, design, manufacturing changes, and regulatory submissions.

You will author assessments, develop strategies, and collaborate with Engineering, Microbiology, Sterility Assurance, and Regulatory Affairs to meet project requirements. Ten percent travel required.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or related science.
• Minimum of 3 years of medical device biocompatibility experience.
• Experience authoring or supporting biocompatibility assessments and testing.
• Experience with reusable or reprocessed medical devices (cleaning/disinfection/sterilization).
• Knowledge of ISO 10993 and regulatory requirements.

Responsibilities

• Lead biocompatibility assessments and reprocessing evaluations for medical device projects.
• Develop evaluation rationales, test strategies, and study designs.
• Coordinate with cross-functional teams (Engineering, Regulatory, Quality).
• Manage testing activities and external laboratory collaborations.
• Prepare and review technical documentation and risk assessments.

Skills

Regulatory knowledge

Biocompatibility testing

Reprocessing know-how

Cross-functional collaboration

Technical writing

MS Office proficiency

AI awareness

Education

Bachelor’s degree in Biology or Chemistry or Engineering

Job description

Teleflex seeks a Biocompatibility Engineer II to join our Global Biocompatibility department in Morrisville, NC. You will independently develop biocompatibility and reprocessing assessments and manage testing activities to support R&D, design, manufacturing changes, and regulatory submissions.

You will author assessments, develop strategies, and collaborate with Engineering, Microbiology, Sterility Assurance, and Regulatory Affairs to meet project requirements. Ten percent travel required.