Senior Process Engineer

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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.