Senior EtO Sterilization Process Engineer

Boston Scientific Gruppe; Coventry, Northern (RI, KY); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific is seeking a Senior Sterilization Engineer to provide technical leadership for EtO sterilization and related quality activities across our global sterilization organization.

The role leads complex initiatives from manufacturing support to validation, compliance and continuous improvement, mentoring cross‑functional teams to ensure patient safety and product quality. This is an on‑site Rhode Island position.

Qualifications

• Bachelor's degree in engineering, science or a related technical discipline.
• Minimum of 5 years' experience in sterilization engineering, manufacturing engineering, process engineering or related field.
• Experience leading technical projects, investigations, or validations from planning through implementation.
• Experience with process development, validation, statistical analysis, and CAPA methodologies.
• Ability to communicate complex technical information to diverse stakeholders.

Responsibilities

• Provide advanced leadership for manufacturing-related sterilization operations and resolve complex issues.
• Lead investigations of significant nonconformances and develop robust technical solutions.
• Serve as SME in EtO sterilization, guiding cross-functional partners.
• Lead development, validation strategies, protocols and reports.
• Drive value improvement and continuous improvement initiatives for process capability and compliance.
• Define technical approaches, acceptance criteria, and risk for sterilization activities.
• Design and analyze experiments using appropriate statistical methods and translate results into actions.
• Author and approve technical reports and validation documentation.
• Mentor engineers and cross-functional teams to share sterilization expertise.
• Ensure compliance with FDA, ISO, EN and other regulatory requirements.

Skills

Sterilization engineering

Process validation

Statistical analysis

Root cause investigations

Education

Bachelor's degree in engineering or science

Job description

Boston Scientific is seeking a Senior Sterilization Engineer to provide technical leadership for EtO sterilization and related quality activities across our global sterilization organization.

The role leads complex initiatives from manufacturing support to validation, compliance and continuous improvement, mentoring cross‑functional teams to ensure patient safety and product quality. This is an on‑site Rhode Island position.