**Senior Microbiologist** _San Jose, CA / Flower Mound, TX_ Stryker is hiring a Senior Microbiologist to support our Endoscopy division. In this role, you will lead the development, review, and approval of sterilization processes and equipment validations (IQ, OQ, PQ) for terminally sterilized products. You will also provide expert microbiological guidance for new product development and drive continuous improvement initiatives for both new and existing products. This is a high-impact role in a fast-paced, innovative environment where you’ll work with cross-functional teams to ensure the highest standards of product safety and compliance. **What you will do:** + Provide guidance on cleaning, disinfection, sterilization, and biocompatibility for reusable medical device design. + Develop, review, and approve sterilization processes and equipment validations (IQ, OQ, PQ). + Maintain and update internal SOPs and work instructions in response to evolving regulatory standards. + Support regulatory submissions (e.g., 510(k)) and collaborate with cross-functional teams and authorities. + Participate in internal and external audits (FDA, notified bodies), addressing sterilization and biocompatibility topics. + Apply ISO, FDA, and other relevant standards to biological and microbiological evaluations of medical products. + Conduct external supplier audits, focusing on cleanroom and sterilization practices. + Review and approve nonconforming material reports and system documentation to ensure compliance. **What you will need:** Basic Qualifications: + Bachelor’s degree in Microbiology, Biology, or a related field. + 2+ years of experience in microbiological or biological testing, R&D, or sterility assurance within the medical device, pharmaceutical or regulated industry. Preferred Qualifications: + Strong knowledge of sterilization techniques and industry standards. + Experience applying ISO and FDA guidelines to product development and manufacturing. + Ability to optimize biocompatibility using advanced testing technologies and regulatory frameworks. $100,400.00 - $160,800.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker 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. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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.