Senior Process Engineer

Boston Scientific • Coventry, RI

8d • $89,200 - $169,500 • Onsite

About The Position

This Senior Sterilization Engineer role will provide technical leadership and subject matter expertise for internal sterilization processing while actively supporting ethylene oxide (EtO) sterilization processes and quality-related activities across our global sterilization organization. The role will independently lead complex technical initiatives spanning manufacturing support, process development, validation, continuous improvement and regulatory compliance. As a senior technical contributor, this individual will influence cross-functional decisions, mentor colleagues and drive solutions that advance operational performance while maintaining a strong commitment to patient safety and product quality.

Requirements

• Bachelor's degree in engineering, science or a related technical discipline.
• Minimum of 5 years' experience in sterilization engineering, manufacturing engineering, process engineering, quality engineering or a related technical field.
• Advanced technical and functional knowledge with demonstrated ability to apply engineering principles to complex sterilization, manufacturing or process-related challenges.
• Demonstrated experience independently leading technical projects, investigations, process improvements or validation activities from planning through implementation.
• Experience with process development, validation, statistical analysis, root cause investigation and corrective and preventive action methodologies.
• Ability to exercise independent technical judgment, evaluate multiple potential solutions and recommend appropriate courses of action for complex or ambiguous problems.
• Demonstrated ability to influence technical decisions and collaborate effectively across manufacturing, quality, engineering and other cross-functional teams.
• Ability to communicate complex technical information, risks and recommendations clearly to technical and nontechnical stakeholders.
• Demonstrated ability to manage multiple priorities and deliver high-quality results with limited direction.
• Working knowledge of applicable quality systems, regulatory requirements and industry standards.

Nice To Haves

• Experience with EtO sterilization processes and sterilization validation.
• Experience supporting medical device manufacturing in an FDA-regulated environment.
• Knowledge of applicable sterilization standards, including relevant ISO requirements.
• Experience applying statistical methods and design of experiments to process development, characterization or validation.
• Experience serving as a technical subject matter expert during internal, regulatory or external audits.
• Demonstrated experience mentoring engineers or providing technical guidance to cross-functional teams.

Responsibilities

• Provide advanced technical leadership for manufacturing-related sterilization operations, independently identifying and resolving complex equipment, process and material-related issues.
• Analyze complaint and process trends, lead investigations of significant nonconformances, and develop robust technical solutions that improve sterilization process performance and reliability.
• Serve as a senior technical expert in EtO sterilization, providing guidance and recommendations to manufacturing, quality and cross-functional partners.
• Lead the development, review, execution and approval of sterilization process validation strategies, protocols and reports.
• Lead value improvement programs and continuous improvement initiatives, identifying opportunities to improve process capability, quality, efficiency and compliance.
• Lead sterilization process development and validation activities, including defining technical approaches, establishing acceptance criteria, assessing risk and authoring applicable protocols and reports.
• Design, execute and analyze complex experiments using appropriate statistical methods, partnering with Corporate Sterilization, Quality Assurance and other technical functions to translate results into actionable recommendations.
• Author and approve technical reports, validation protocols, validation reports and other documentation supporting EtO sterilization processes.
• Lead technical investigations of deviations and nonconformances, determine root causes, and develop and implement effective corrective and preventive actions.
• Interpret and apply site, corporate and regulatory requirements, including applicable FDA, ISO, EN and other standards, to ensure sustained process compliance.
• Develop, improve and maintain operating procedures, technical standards and associated training materials to support consistent execution and regulatory compliance.
• Own and maintain critical processing specifications and documentation, including load configurations, sterilization specifications and manufacturing documentation.
• Provide technical review and approval of process change controls, specifications and other documentation, assessing potential impacts to sterilization processes, product quality and regulatory compliance.
• Serve as a sterilization process subject matter expert during internal and external audits, providing technical rationale and supporting responses to audit observations as appropriate.
• Provide technical guidance and mentorship to engineers and cross-functional partners, sharing expertise and promoting consistent application of sterilization engineering principles.
• Influence cross-functional technical decisions and proactively identify opportunities, risks and solutions that support business and organizational objectives.
• 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.

Benefits

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
• Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
• At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior