Boston Scientific Process Engineer 

United States, Rhode Island 

624143831

About the role:
Boston Scientific is looking for a highly motivated engineer who will be responsible for facilitating research & development, troubleshooting processes and equipment, and executing process improvements to meet business requirements while implementing policies for sustained site compliance. This is an opportunity to grow and serve as a subject matter expert (SME) for Ethylene Oxide (EO)sterilization equipment and process, abatement systems, and emissions monitoring equipment.

Your responsibilities will include:

• Provide support for sterilization operations by troubleshooting sterilization equipment, and processes, performing complaint trend review, process capability analysis and statistical process control.
• Support sterilization process development and validation activities as required including development of applicable protocols and reports.
• Lead and support equipment, process, and software validation activities for sterilization processes, abatement systems, and continuous emissions monitoring systems.
• Support value improvement programs and lead other continuous improvement activity.
• Create, execute, and analyze experiments using statistical methods, including working with the Corporate Sterilization and QA teams.
• Review internal deviations, investigate and implement corrective and preventive actions to ensure compliance to procedures and regulatory requirements.
• Ensure compliance to site, Corporate, FDA, ISO, EN, EPA, RIDEM and other regulatory requirements
• Develop and maintain operating procedures and associated training material to ensure compliance with industry and regulatory standards
• Maintain processing specifications and required documents to include load configuration, sterilization specifications and manufacturing documents, as needed
• Review / Approve process change control documentation and specifications; Support the organization as the process subject matter expert during audits.
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on all sterilization equipment and processes.

Required qualifications:

• Bachelor's Degree in Biomedical Engineering
• 1+ year of experience in an engineering role
• Experience in the medical device industry
• Demonstrated engineering fundamentals and problem-solving skills

Preferred qualifications:

• Master’s Degree
• Previous BSC Experience

• Excels in a collaborative, cross-functional, cross-site environment.
• Fixture and equipment design or trouble shooting experience (CAD experience not required).