Biological Safety Cleaning & Disinfection Engineer

Philips•Murrysville, PA

13d•$74,000 - $117,000•Onsite

About The Position

Your role: Leading the preparation and documentation for biocompatibility, cleaning, and disinfection activities, creating testing strategies and dossiers for Sleep & Respiratory Care devices. Managing testing with external labs and interpreting CRO results. Learning, following, and continuously updating internal QMS procedures, work instructions, and forms. Ensuring compliance and keeping documentation aligned with evolving quality standards. Developing and delivering training programs to support cross‑functional understanding of biological safety processes. Providing weekly project status updates to keep stakeholders informed. Supporting development teams by advising on appropriate materials for medical device use, ensuring safety, regulatory compliance, and alignment with biological risk requirements. Collaborating cross‑functionally with R&D, NPD, CROs, regulatory agencies, and internal/external scientists to safeguard thorough evaluations, smooth workflows, and successful execution of testing strategies.

Requirements

2+ years of experience in cleaning and disinfection, reprocessing, sterilization sciences, materials compatibility (or similar), within medical device development (preferred), or no prior experience required with a co-op or internship related to the above
Experience executing or supporting cleaning and/or disinfection validation testing (preferred)
Working knowledge of root cause analysis and participation in failure investigations and CAPA activities (preferred)
Familiarity with applicable standards and regulations such as ISO 17664, ISO 10993 (as applicable), FDA reprocessing guidance, and EU MDR (preferred)
Bachelor's degree in Engineering (Chemical, Materials Science or Bio Engineering preferred) or similar discipline
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
Excellent communicator, both written and verbal, and have strong practices in documentation

Nice To Haves

Experience executing or supporting cleaning and/or disinfection validation testing
Working knowledge of root cause analysis and participation in failure investigations and CAPA activities
Familiarity with applicable standards and regulations such as ISO 17664, ISO 10993 (as applicable), FDA reprocessing guidance, and EU MDR

Responsibilities

Leading the preparation and documentation for biocompatibility, cleaning, and disinfection activities
Creating testing strategies and dossiers for Sleep & Respiratory Care devices
Managing testing with external labs and interpreting CRO results
Learning, following, and continuously updating internal QMS procedures, work instructions, and forms
Ensuring compliance and keeping documentation aligned with evolving quality standards
Developing and delivering training programs to support cross‑functional understanding of biological safety processes
Providing weekly project status updates to keep stakeholders informed
Supporting development teams by advising on appropriate materials for medical device use, ensuring safety, regulatory compliance, and alignment with biological risk requirements
Collaborating cross‑functionally with R&D, NPD, CROs, regulatory agencies, and internal/external scientists to safeguard thorough evaluations, smooth workflows, and successful execution of testing strategies