Job Overview The Sterilization Engineer will play a critical role in ensuring the development and maintenance of sterilization processes for medical devices. This position will support cross-functional teams within the organization, driving initiatives related to sterilization standards, validation, and compliance with regulatory requirements. This is a technical role that requires a strong understanding of electrical, scientific, or general engineering principles, as well as a specialized focus on sterilization processes, materials, and testing within a regulated environment.
Responsibilities Design, implement, and validate sterilization processes to meet industry standards and regulatory requirements.Develop and execute sterilization validation protocols, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) as needed for new and existing products.Provide technical expertise in sterilization methods, material compatibility, and process optimization.Troubleshoot and resolve issues related to sterilization processes and equipment, implementing corrective and preventive actions (CAPA).Prepare and maintain technical documentation, risk assessments, and process validations related to sterilization.Act as the subject matter expert (SME) for sterilization during regulatory audits and inspections.Participate in design reviews to ensure sterilization needs are considered early in the product lifecycle.Support continuous improvement initiatives in sterilization processes, aiming to enhance product quality, efficiency, and compliance.Qualifications/Experience Bachelor's degree in electrical engineering, Mechanical Engineering, Biomedical Engineering, or a related scientific/engineering field.3-5 years of experience in an engineering role within the medical device or healthcare industry, with a focus on sterilization processes.Demonstrated experience with sterilization methods and standards.
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