Senior Manufacturing Engineer

The Senior Manufacturing Engineer is a highly hands-on technical leader responsible for supporting day-to-day manufacturing operations, troubleshooting equipment and process issues, and developing, building, and qualifying new manufacturing equipment. This role will serve as a key resource for equipment reliability, automation, process improvement, and production data analysis within a regulated combination product environment.

The Senior Manufacturing Engineer will independently diagnose mechanical, electrical, pneumatic, controls, and software-related issues affecting production, yield, quality, and throughput. This position will also maintain and improve a web-based manufacturing dashboard that utilizes production data from Ignition, ensuring data accuracy, system functionality, and effective visualization of manufacturing performance.

This role works closely with Operations, Quality, R&D, and external suppliers to maintain production readiness, minimize downtime, improve equipment performance, and support the scale-up of manufacturing operations while maintaining compliance with FDA, ISO 13485, GMP, and internal quality system requirements.

Essential Duties and Responsibilities

• Provide hands-on support on the manufacturing floor by independently troubleshooting and resolving equipment, tooling, automation, and process issues affecting production, yield, quality, and throughput.
• Diagnose and correct mechanical, electrical, pneumatic, instrumentation, controls, and basic software issues.
• Interpret electrical schematics, pneumatic diagrams, equipment drawings, and technical documentation to support troubleshooting and equipment development.
• Serve as equipment owner for assigned manufacturing systems, including performance monitoring and reliability improvement.
• Lead the design, fabrication, integration, commissioning, and implementation of new manufacturing equipment, fixtures, tooling, and automation.
• Develop equipment requirements, functional specifications, risk assessments, test plans, and commissioning documentation.
• Partner with internal teams and suppliers on equipment design, build, troubleshooting, factory acceptance testing, site acceptance testing, and equipment handoff.
• Support equipment and process qualification activities, including IQ, OQ, and PQ, with minimal supervision.
• Own change controls, engineering assessments, deviations, nonconformances, CAPAs, and other quality system activities related to manufacturing equipment and processes.
• Perform structured root cause analysis and implement effective corrective and preventive actions.
• Maintain and improve the web-based manufacturing dashboard, including data connections, calculations, visualizations, user functionality, and performance metrics derived from Ignition production data.
• Partner with Operations, IT, and Engineering to investigate data integrity or dashboard functionality issues and ensure production metrics are accurate, accessible, and actionable.
• Support new product introductions, design transfers, and engineering changes by assessing manufacturability, scalability, process capability, and equipment readiness.
• Collaborate with Quality to ensure equipment and process changes comply with FDA, ISO 13485, GMP, and internal quality system requirements.
• Create and maintain technical documentation, work instructions, troubleshooting guides, protocols, reports, and equipment records.
• Promote safe work practices and ensure compliance with applicable environmental, health, and safety requirements, particularly when working with chemical processes and production equipment.
• Train and mentor Manufacturing Engineers I and II, manufacturing technicians, and production personnel on equipment operation, troubleshooting methods, and best practices.
• Contribute to manufacturing scale-up through equipment upgrades, line expansions, process standardization, and production readiness activities.

Supervisory Responsibilities

This position may provide technical direction, training, and mentorship to Manufacturing Engineers and manufacturing technicians. Formal supervisory responsibilities may vary based on organizational needs.