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.
Travel Percentage: 10%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.