Work Flexibility: Hybrid

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.

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.