Boston Scientific Process Engineer II 

United States, Rhode Island 

790488713

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 Engineering related field
• 2+ years of experience post education in an engineering role
• Demonstrated engineering fundamentals and problem-solving skills

Preferred qualifications:

• Engineering in Biomedical, Chemical, Mechanical, Electrical, Electromechanical, and Polymer.
• Excels in a collaborative, cross-functional, cross-site environment.
• Fixture and equipment design or trouble shooting experience (CAD experience not required).
• Medical device or other regulated industry experience.
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.