R&D Sterile Disposables Senior Engineer (Microbiology & Biocompatibility) - Indianola, PA

Role: R&D Sterile Disposables Senior Engineer specializing in Microbiology and Biocompatibility, supporting medical device development and validation. Responsibilities: design and execute microbiological, chemical compatibility, and biocompatibility testing; develop and validate test methods; ensure compliance with global standards (ISO 10993, USP); coordinate with external labs; support reprocessing validation, microbial ingress and simulated use testing, and biocompatibility assessments; prepare technical documentation and present findings. Requirements: Bachelor’s in Microbiology, Chemistry, Biomedical Engineering, or related; 5–7 years of relevant experience; strong microbiology lab skills, knowledge of GMP/GxP, and familiarity with medical device sterilization and biocompatibility. Preferred: Master’s degree, experience with FDA submissions, sterilization, and analytical chemistry techniques. High-Value: medical device microbiology, chemical compatibility, biocompatibility, ISO 10993, sterile disposables, regulatory compliance. Work setup: based in Indianola, PA, with no specified travel requirements.