Process Engineer II

Boston Scientific•Coventry, RI

2d•$75,100 - $142,600•Onsite

About The Position

This role will focus primarily on internal sterilization processing while actively participating in ethylene oxide (EtO) sterilization processes and quality-related activities that support our global sterilization organization. The role provides technical expertise across manufacturing support, process development, validation, continuous improvement and regulatory compliance, with a commitment to patient safety and product quality. Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

Requirements

Expanded conceptual, technical and functional knowledge within the job function, with the ability to apply relevant concepts to sterilization engineering activities.
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 work within established guidelines and policies while contributing to the quality of individual and team deliverables.
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.