Biocompatibility/Reprocessing Engineer II

Teleflex•Durham, NC

10d•Onsite

About The Position

Teleflex is seeking a Biocompatibility Engineer II to join our Global Biocompatibility department. The successful candidate will independently develop biocompatibility and reprocessing assessments and manage associated testing activities to support R&D, design and manufacturing changes, regulatory submissions, and other medical device projects. The Biocompatibility Engineer II will independently manage routine to moderately complex projects and apply scientific and engineering judgment to develop appropriate evaluation and testing strategies, with consultation from other subject matter experts as needed. This position is based at our Morrisville, NC office.

Requirements

Bachelor’s degree in Biology, Chemistry, Engineering, or other related science, with strong chemistry and/or biology background required.
Minimum of 3 years of relevant medical device experience in biocompatibility, biological evaluation, reprocessing, or other related technical functions.
Working knowledge of regulatory requirements for biocompatibility, including the ISO 10993 series and applicable regional regulatory requirements.
Working knowledge of reusable medical device reprocessing requirements and applicable standards, including ISO 17664 and ISO 17665.
Working knowledge of biological evaluation within a risk management process, including development of testing strategies, representative test article selection, sample preparation, and interpretation of biological test results.
Working knowledge of reusable medical device reprocessing, including cleaning, disinfection, sterilization, repeated processing, and associated evaluation and testing strategies.
Basic understanding of chemical characterization and toxicological risk assessment principles.
Ability to independently author and review biocompatibility and reprocessing technical assessments for routine to moderately complex medical device projects.
Strong written and verbal communication, problem-solving, project management, and cross-functional collaboration skills.
Ability to organize and independently manage assigned projects and recognize when additional technical expertise or escalation is required.
Demonstrated proficiency in MS Office (Word, Excel, Access, PowerPoint, Outlook, SharePoint).
Familiarity with artificial intelligence (AI) tools and their appropriate use to support research, data review, technical writing, and workflow efficiency, with appropriate verification of AI-assisted outputs.
Ability to work effectively both cross-functionally and as an individual contributor.
Foster a positive culture of growth, collaboration, and achievement across the organization.

Nice To Haves

Experience authoring or supporting medical device biocompatibility assessments and associated testing activities strongly preferred.
Experience with reusable or reprocessed medical devices, including cleaning, disinfection, sterilization, and/or repeated processing, preferred.

Responsibilities

Independently author biocompatibility assessments and reprocessing assessments for assigned medical device projects in accordance with applicable procedures, standards, and regulatory requirements.
Develop appropriate evaluation rationales and testing strategies based on available product, material, manufacturing, processing, historical, and testing information.
Serve as the primary technical point of contact for assigned projects and collaborate with Engineering, Microbiology, Sterility Assurance, Regulatory Affairs, Quality, and other cross-functional team members to define and execute project requirements.
Develop and manage biocompatibility testing activities, including representative test article selection, sample preparation, extraction conditions, test methods, and external laboratory activities.
Support reprocessing activities for reusable medical devices, including assessment of cleaning, disinfection, sterilization, and repeated processing, and development of appropriate reprocessing evaluation and testing strategies.
Review applicable protocols, reports, and test results and determine whether additional testing, rationale, risk assessment, or technical consultation is necessary.
Create and review technical documentation, including Biological Risk Assessments, Biological Evaluation Plans, Biological Evaluation Reports, reprocessing assessments, and other applicable technical documentation.
Support chemical characterization and toxicological risk assessment activities and coordinate with qualified toxicology personnel when additional toxicological assessment is required.
Participate in assessments of changes to applicable standards, guidance documents, and regulatory requirements and maintain working knowledge of evolving industry expectations.
Support development and delivery of training on biocompatibility, reprocessing, and relevant technical topics, as needed.
Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures.
Complete other duties and tasks as assigned.