Senior Manufacturing Engineer

Katalyst CRO; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO seeks a Senior Manufacturing Engineer in Cambridge, MA to advance and optimize manufacturing processes, support validation, and drive continuous improvement across production lines. The role emphasizes root-cause analysis, CAPA, and QN tracking in SAP, while collaborating with Quality, R&D, and Supply Chain to meet regulatory and quality standards.

The ideal candidate will bring 8+ years of experience in manufacturing engineering, strong project management skills, and hands-on

Qualifications

• BS/BA degree in Management, Operations, Engineering, or a closely related field.
• 8+ years of experience in Senior Manufacturing Engineering.
• Experience with root cause analysis of production process failures.
• Experience with PFMEA, IQ, TMV, OQ/PQ, and statistical analysis of process data.
• Understanding of GD&T on mechanical drawings.
• Knowledge of manufacturing production lines.
• Experience in project management activities.
• Knowledge of process validation.
• Basic understanding of Operational Excellence incl. Lean and problem solving.
• Proficiency with SAP, Power Apps, Windchill, PDF Writer, and MS Office.

Responsibilities

• Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Support manufacturing production lines, process validation, and continuous improvement initiatives.
• Lead and support First Article Inspection (FAI) activities to ensure regulatory compliance.
• Create, manage, and track Quality Notifications (QN) in SAP for nonconformances and issues.
• Manage deviations, CAPA, and improvements through SICR.
• Utilize SAP for production planning, material management, inventory tracking, and reporting.
• Collaborate with Quality, R&D, Supply Chain, and Production to resolve issues.
• Analyze data and apply Lean/Six Sigma strategies for continuous improvement.
• Support root-cause analysis and implement CAPA actions.
• Ensure compliance with ISO 9001, ISO 13485, and FDA regulations.
• Host meetings, document actions, assign owners, and track progress.
• Communicate with Project Leads to align projects with goals.
• Use Power Apps, Windchill, PDF Writer, and MS Office daily.

Skills

Lean Manufacturing

Six Sigma

Project Management

Process Improvement

Education

BS/BA degree in Management/Operations/Engineering

Tools

SAP

Power Apps

Windchill

PDF Writer

MS Office

Job description

• The Senior Manufacturing Engineer will be responsible for developing, implementing, and optimizing manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• The role supports manufacturing production lines, process validation, continuous improvement initiatives, project management activities, and ensures compliance with ISO 9001, ISO 13485, and FDA standards.
• Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Lead and support First Article Inspection (FAI) activities to ensure products meet design and regulatory requirements.
• Create, manage, and track Quality Notifications (QN) in SAP for nonconformances, defects, and process issues.
• Manage and document process deviations, corrective actions, and improvements through SICR (Supplier/Internal Corrective Reports).
• Utilize SAP for production planning, material management, inventory tracking, and reporting.
• Collaborate with Quality, R&D, Supply Chain, and Production teams to resolve issues and improve manufacturing processes.
• Analyze manufacturing data and implement continuous improvement strategies using Lean and Six Sigma methodologies.
• Support root cause analysis and implement corrective and preventive actions (CAPA).
• Ensure compliance with industry standards, safety requirements, ISO 9001, ISO 13485, and FDA regulations.
• Support manufacturing production lines and project management activities.
• Support and execute process validation activities.
• Host daily and weekly meetings, document action items, assign owners, track due dates, and monitor progress.
• Communicate with Project Leads to keep projects aligned with established goals.
• Utilize Power Apps, Windchill, PDF Writer, and MS Office in day-to-day activities.

Job Summary

• The Senior Manufacturing Engineer will be responsible for developing, implementing, and optimizing manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• The role supports manufacturing production lines, process validation, continuous improvement initiatives, project management activities, and ensures compliance with ISO 9001, ISO 13485, and FDA standards.
• Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Lead and support First Article Inspection (FAI) activities to ensure products meet design and regulatory requirements.
• Create, manage, and track Quality Notifications (QN) in SAP for nonconformances, defects, and process issues.
• Manage and document process deviations, corrective actions, and improvements through SICR (Supplier/Internal Corrective Reports).
• Utilize SAP for production planning, material management, inventory tracking, and reporting.
• Collaborate with Quality, R&D, Supply Chain, and Production teams to resolve issues and improve manufacturing processes.
• Analyze manufacturing data and implement continuous improvement strategies using Lean and Six Sigma methodologies.
• Support root cause analysis and implement corrective and preventive actions (CAPA).
• Ensure compliance with industry standards, safety requirements, ISO 9001, ISO 13485, and FDA regulations.
• Support manufacturing production lines and project management activities.
• Support and execute process validation activities.
• Host daily and weekly meetings, document action items, assign owners, track due dates, and monitor progress.
• Communicate with Project Leads to keep projects aligned with established goals.
• Utilize Power Apps, Windchill, PDF Writer, and MS Office in day-to-day activities.

Roles & Responsibilities:

• The Senior Manufacturing Engineer will be responsible for developing, implementing, and optimizing manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• The role supports manufacturing production lines, process validation, continuous improvement initiatives, project management activities, and ensures compliance with ISO 9001, ISO 13485, and FDA standards.
• Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Lead and support First Article Inspection (FAI) activities to ensure products meet design and regulatory requirements.
• Create, manage, and track Quality Notifications (QN) in SAP for nonconformances, defects, and process issues.
• Manage and document process deviations, corrective actions, and improvements through SICR (Supplier/Internal Corrective Reports).
• Utilize SAP for production planning, material management, inventory tracking, and reporting.
• Collaborate with Quality, R&D, Supply Chain, and Production teams to resolve issues and improve manufacturing processes.
• Analyze manufacturing data and implement continuous improvement strategies using Lean and Six Sigma methodologies.
• Support root cause analysis and implement corrective and preventive actions (CAPA).
• Ensure compliance with industry standards, safety requirements, ISO 9001, ISO 13485, and FDA regulations.
• Support manufacturing production lines and project management activities.
• Support and execute process validation activities.
• Host daily and weekly meetings, document action items, assign owners, track due dates, and monitor progress.
• Communicate with Project Leads to keep projects aligned with established goals.
• Utilize Power Apps, Windchill, PDF Writer, and MS Office in day-to-day activities.

Education & Experience:

• BS/BA degree in Management, Operations, Engineering, or a closely related field.
• Minimum 8+ years of experience in Senior Manufacturing Engineering.
• Experience in root cause analysis of production process failures and troubleshooting production equipment issues.
• Experience with process validation documentation including PFMEA, IQ, TMV, OQ/PQ, and statistical analysis of process data.
• Understanding of geometric dimensioning and tolerancing (GD&T) on mechanical drawings.
• Knowledge of manufacturing production lines.
• Experience in project management activities.
• Knowledge of process validation.
• Basic understanding of business processes.
• Basic knowledge of Operational Excellence, including Lean Manufacturing and problem-solving methodologies.
• Proficiency with SAP, Power Apps, Windchill, PDF Writer, and MS Office.