Senior Process Engineer

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: 
In this role, you 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. You will also serve as a mentor and guide engineers and technicians, ensuring the site aligns with department and company objectives. 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:

• Interface regularly with management, production supervisors, process engineers, maintenance/process technicians, and operators to maintain an awareness of equipment or process-related issues.
• As an SME, provide ongoing support for sterilization operations that includes process improvements, troubleshooting of sterilization equipment, complaint trend review, and resolving non-conformances.
• As an SME, perform equipment and process hazard assessments. Identify and implement risk mitigation strategies. Lead and support equipment, process, and software validation activities.
• Support the development, review, and approval of sterilization cycles and associated validation activities. 
• Partner with relevant departments to ensure compliance with relevant standards as well as site and corporate procedures. Ensure compliance with requirements from RIDEM, EPA, FDA, OSHA, ISO, EN, and ‘other regulatory bodies.
• Maintain processing specifications and manufacturing documents.
• Support and lead continuous improvement activities. 
• Closely monitor equipment downtime and non-conformance trends. Identify ways to prevent and eliminate them. Monitor PM effectiveness.
• Participate and lead root cause analysis, identify and implement corrective actions.
• Continually analyze training needs and organize plans to close the identified technical gaps.
• Review and approve process change control documentation and specifications.
• Create, execute, and analyze experiments using robust statistical methods such as DOE.
• Prepare ethylene oxide sterilization technical reports, validation protocols, and validation reports.
• Review internal deviations, investigate, and implement corrective and preventive actions to ensure compliance with procedures and regulatory requirements.
• Manage relationships with outside equipment suppliers and vendors.
• Provide leadership role by serving as a mentor for other engineers and technicians.

Required qualifications:

• Bachelor's degree and 5+ years or Master's degree and 3+ years of relevant experience in a regulated industry. (Engineering degree in Mechanical, Electromechanical, Chemical, Polymer, Industrial or related field.)
• Experience developing, executing, and reviewing equipment and process validation related activities.
• Experience with statistical analysis, root cause analysis, and structured problem-solving.
• Experience with working on different industrial sensors (humidity, temperature, pressure, airflow)
• Experience with implementing semi-automated processes in a manufacturing setup. Knowledge of equipment interface and serial communication protocols (MODBUS/TCP-IP/RS232/RS485)

Preferred qualifications:

• Basic knowledge of Automation, PLC programming, communication protocols, equipment interface 
• Knowledge of equipment, software, and process validation; Lean Six Sigma tools.
• Demonstrated effective communication with multiple stakeholders at different levels within the organization and with suppliers and equipment vendors. Continuous improvement mindset
• Experience with HVAC, chiller, liquid ring vacuum pumps, blowers and fans, valves, P&ID
• Basic knowledge of SolidWorks or AutoCAD
• Basic knowledge of Minitab/Power BI/Tableau

#LI-Onsite
 

Requisition ID: 575856

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