EtO Sterilization Process Engineer II

Boston Scientific; Coventry (RI); On-site; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific in Rhode Island is seeking an EtO sterilization engineer focused on internal sterilization processing and supporting global sterilization operations. The role requires technical expertise across manufacturing support, process development, validation, continuous improvement, and regulatory compliance to ensure patient safety and product quality.

You will work on process development and validation, perform experiments with statistical methods, review deviations, and contribute to

Qualifications

• Expanded conceptual, technical and functional knowledge within the job function.
• Working knowledge of business and industry practices and company processes needed to accomplish assigned work.
• Ability to exercise judgment to solve problems in straightforward situations and determine appropriate actions and solutions.
• Ability to work under general direction from more senior-level colleagues or management while remaining accountable for individual contributions and objectives.
• Ability to organize, present and explain data and factual information to internal audiences.

Responsibilities

• Provide ongoing technical support for manufacturing-related sterilization operations, including process improvements and troubleshooting of sterilization equipment, processes and material-related issues.
• Review complaint trends, investigate and resolve nonconformances, and provide sterilization engineering support to manufacturing operations.
• Serve as a technical expert in the EtO sterilization process.
• Support the development, review and approval of sterilization process validation activities.
• Support value improvement programs and lead continuous improvement activities.
• Support sterilization process development and validation activities, including the development of applicable protocols and reports.
• Create, execute and analyze experiments using statistical methods, collaborating with Corporate Sterilization and Quality Assurance teams as appropriate.
• Prepare sterilization technical reports, validation protocols and validation reports for EtO sterilization.
• Review internal deviations and investigate and implement corrective and preventive actions to support compliance with procedures and regulatory requirements.
• Ensure compliance with site and corporate requirements, as well as applicable FDA, ISO, EN and other regulatory requirements.
• Develop and maintain operating procedures and associated training materials to support compliance with industry and regulatory standards.
• Maintain processing specifications and required documentation, including load configurations, sterilization specifications and manufacturing documents, as needed.
• Review and approve process change control documentation and specifications.
• Serve as a sterilization process subject matter expert during audits.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Job description

Boston Scientific in Rhode Island is seeking an EtO sterilization engineer focused on internal sterilization processing and supporting global sterilization operations. The role requires technical expertise across manufacturing support, process development, validation, continuous improvement, and regulatory compliance to ensure patient safety and product quality.

You will work on process development and validation, perform experiments with statistical methods, review deviations, and contribute to