Job Title: Sterilisation Engineer
The Sterilisation Engineer plays a crucial role in developing and maintaining sterilization processes for medical devices. This position supports cross-functional teams, driving initiatives related to sterilization standards, validation, and regulatory compliance.
About the Role:
* Design, implement, and validate sterilisation processes to meet industry standards and regulatory requirements.
* Develop and execute sterilisation validation protocols, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) as needed for new and existing products.
* Provide technical expertise in sterilisation methods, material compatibility, and process optimization.
* Troubleshoot and resolve issues related to sterilisation processes and equipment, implementing corrective and preventive actions (CAPA).
* Prepare and maintain technical documentation, risk assessments, and process validations related to sterilisation.
* Act as the subject matter expert (SME) for sterilisation during regulatory audits and inspections.
* Participate in design reviews to ensure sterilisation needs are considered early in the product lifecycle.
Requirements:
* 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 sterilisation methods and standards.
Salary: $120,000 - $150,000 per year
Description:
This is a technical role that requires a strong understanding of electrical, scientific, or general engineering principles. The ideal candidate will have excellent analytical and problem-solving skills, with the ability to work effectively in a team environment.
In this role, you will be responsible for designing, implementing, and validating sterilisation processes to meet industry standards and regulatory requirements. You will also develop and execute sterilisation validation protocols, provide technical expertise in sterilisation methods, and troubleshoot issues related to sterilisation processes and equipment.
As the Sterilisation Engineer, you will play a critical role in ensuring the development and maintenance of sterilization processes for medical devices. If you have a strong background in engineering and a passion for sterilization processes, we encourage you to apply for this exciting opportunity.