Biocompatibility/Reprocessing Engineer II

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

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

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.

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.

Education / Experience 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.
• 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.

Specialized Skills / Other Requirements

• 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.

TRAVEL REQUIRED: Up to 10%

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].