Senior Process Engineer

Senior Process Engineer

Work mode:
Onsite Onsite Location(s):
Coventry, RI, US, 02816 Additional Location(s): N/A Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

About the role:

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. In this role, you will serve as a subject matter expert on Boston Scientific's internal ethylene oxide (EtO) sterilization processes, related equipment, procedures, documentation and applicable external standards.

Your primary focus will be supporting internal sterilization processing while actively participating in EtO sterilization process and quality activities across our global sterilization organization.

Work model, sponsorship, relocation:
This is an on-site role based in Coventry. Regular on-site presence is required to support manufacturing and sterilization operations. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is available for this position.

Your responsibilities will include:

• Serve as a technical subject matter expert for EtO sterilization processes, equipment, procedures, documentation and applicable standards.
• Provide ongoing sterilization engineering support for manufacturing operations, including process improvements and troubleshooting sterilization equipment, process and material issues.
• Review complaint trends, investigate and resolve nonconformances, and support corrective and preventive actions.
• Support the development, review and approval of sterilization process validation activities.
• Support value improvement programs and lead continuous improvement activities related to sterilization processes and operations.
• Support sterilization process development and validation activities, including developing applicable protocols and reports.
• Create, execute and analyze experiments using appropriate statistical methods in collaboration with Corporate Sterilization and Quality Assurance teams.
• Prepare technical reports, validation protocols and validation reports for EtO sterilization processes.
• Review internal deviations and investigate and implement corrective and preventive actions to maintain compliance with procedures and regulatory requirements.
• Ensure compliance with site and corporate requirements and 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 the sterilization process subject matter expert during audits.
• Support team members by setting an example and providing coaching, feedback and guidance.
• Lead small projects or project phases with manageable risks and resource requirements.
• Exchange complex technical information with cross-functional partners and participate in meetings and presentations to clearly communicate key messages.

Qualifications:

Required qualifications:

In-depth conceptual, practical and technical knowledge of principles and theories related to the role, with a general understanding of related functions. Demonstrated experience applying technical and functional knowledge across a variety of situations to accomplish objectives. Ability to understand key business drivers and how closely related teams collaborate to accomplish objectives and improve efficiency. Demonstrated ability to solve problems of varying scope and complexity, applying established solutions while exercising judgment and proposing appropriate alternatives.

Ability to work independently within company policies, guidelines and procedures while seeking guidance for complex or unprecedented situations. Ability to communicate complex information effectively and collaborate with cross-functional teams.

Preferred qualifications:

Experience with EtO sterilization processes, sterilization equipment and manufacturing operations. Experience supporting sterilization process development and validation activities. Experience developing and executing validation protocols, technical reports and controlled documentation. Experience…