**What you wiil do** As a Staff Microbiologist, you will lead microbiological testing and sterilization validation processes to ensure product safety and regulatory compliance. You will also serve as a subject matter expert for microbiological activities within the project, providing support during audits, mentoring team members, and coordinating with external labs. **Key Responsibilities:** + Perform microbiological testing (e.g., bioburden, endotoxin, microbial ID, growth promotion) using qualified equipment and approved procedures, ensuring reliable and accurate results. + Review and approve microbiological testing data, ensuring compliance with applicable standards and regulatory requirements (cGLP, cGMP, FDA, ISO, ANSI, AAMI, USP, EPA). + Lead the validation of sterilization processes and equipment (IQ, OQ, PQ), ensuring alignment with project requirements and current industry standards. + Coordinate and conduct environmental monitoring in controlled manufacturing areas, and prepare detailed reports and monthly metrics to support quality systems. + Review and approve change control documentation, specifications, and nonconformance records related to microbiological aspects of the project. + Provide microbiology support during product transfers and process development for both new and existing products, including supplier quality interactions. + Mentor and train laboratory personnel on microbiology testing methods, environmental control procedures, and equipment use to ensure consistency and compliance. + Support internal and external audits, manage external lab testing, and contribute to biocompatibility and sterility documentation for regulatory submissions. **What you need** Required: + B.S. in Microbiology, Biology, or related discipline. + At least 4+ years of method validation experience in medical devices or highy related industries. + Fluent in both English and Spanish. + Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures. + Demonstrated knowledge on the fundamentals of sterilization process. + Experience conducting laboratory testing. + Knowledge in identification of microorganisms. + Knowledge in microbiology lab equipment installation and operational qualification validations. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.