Senior Process Engineer

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026 and by Glassdoor as a Best Place to Work in 2026, ranking No. 15 on the Top 100 list. This role offers the opportunity to work in a culture of innovation, collaboration, and high performance while advancing your skills and career.

About The Role

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.

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.

Responsibilities

• 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 applying statistical methods to process development, validation, or continuous improvement activities.
• Knowledge of applicable FDA, ISO, EN, and other regulatory or industry requirements related to sterilization.
• Experience investigating deviations and nonconformances and supporting corrective and preventive actions.
• Experience supporting audits as a technical or process subject matter expert.

Quality System Requirements

• In all actions, 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.
• For individuals who supervise others:
  • Ensure appropriate resources, including personnel and tools, are maintained to support Quality System compliance and adherence to the Boston Scientific Quality Policy.
  • Establish and promote a work environment that supports the Quality Policy and Quality System.

Pay

The anticipated compensation range for this role is $89,200 to $169,500. Compensation will vary based on actual location, experience, education, and other relevant factors. Core and optional employee benefits are available; see www.bscbenefitsconnect.com for details.

For non-exempt (hourly), non-sales roles, compensation may also include variable pay such as overtime, shift differentials, and annual bonus targets (subject to eligibility). For exempt, non-sales roles, compensation may include annual bonus targets and long-term incentives (subject to eligibility).