**What you will do-** This role leads the development and implementation of testing protocols, ensuring compliance with medical device regulations and standards. The position plays a key role in cross-functional projects, supporting new product development, sustaining activities, and quality initiatives. As a subject matter expert (SME), the individual will guide others, influence internal and external stakeholders, and drive process improvements aligned with global regulatory expectations. + Lead the development of compliant testing protocols for sterilized medical devices, supporting both new product development and sustaining engineering. + Act as a subject matter expert (SME) during business development activities, audits, quality investigations, and cross-functional initiatives. + Interpret and apply international standards related to sterilization, cleaning, disinfection, and biocompatibility, while mentoring junior staff. + Lead or contribute to quality system improvements, including authoring or revising procedures and serving as a Divisional Process Owner (DPO). + Guide technical problem-solving, including addressing customer complaints, non-conformances, and field actions, using strong technical expertise. + Apply knowledge of clinical use, manufacturing processes, and financial impacts to enhance product development and testing strategies. + Represent the company in industry standards development, advise on regulatory changes, and ensure global compliance across divisions. + Collaborate across R&D, Quality, Regulatory, and Marketing teams, leading and mentoring others to ensure project success and alignment with business goals. **What you need-** Required: + Bachelor’s degree in biology, Microbiology, Chemistry, or Biomedical Engineering. + Minimum of 6 years of relevant work experience. + Ability to occasionally lift to 10 pounds (light physical work). Manual dexterity and coordination of eye, hand, and foot movements. Ability to grasp objects by hand. Desired + Strong knowledge of FDA, GMP, ISO, and other medical device regulatory requirements. + Proficient in cleaning, disinfection, sterilization validation, and biocompatibility testing within regulated environments. + In-depth expertise with multiple sterilization methods (e.g., irradiation, ethylene oxide, vaporized hydrogen peroxide, moist heat). + Skilled in interpreting and developing standards, analyzing test results, and resolving validation issues. + AAMI CISS certification. 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.