Position SummaryThe Senior Manufacturing Engineer will provide hands-on manufacturing engineering support to operations, with a focus on line support, continuous improvement, capacity optimization, and new product transfers. This role will drive improvements in manufacturing efficiency, quality, productivity, material flow, ergonomics, and equipment utilization while applying data-driven problem solving, statistical analysis, Lean methodologies, and root cause analysis.
The Senior Manufacturing Engineer will partner closely with Operations, Quality, Maintenance, Product Development, and other cross-functional teams to identify opportunities, resolve complex manufacturing issues, implement sustainable improvements, and support the successful introduction of new products and processes.
Key ResponsibilitiesManufacturing & Line Support- Provide technical oversight and monitoring of manufacturing equipment and processes, including coordination of equipment maintenance, upgrades, repairs, and improvements.
- Provide hands-on troubleshooting and technical support for manufacturing equipment, processes, tooling, and fixtures.
- Troubleshoot complex manufacturing issues and identify effective, sustainable solutions.
- Lead and own CAPA activities related to production and customer issues, utilizing structured root cause analysis and ensuring timely implementation and effectiveness of corrective and preventive actions.
- Lead formal failure analysis and issue-resolution activities to identify root causes and implement preventive actions.
- Identify, develop, and implement Good Manufacturing Practices (GMP) appropriate to assigned production areas.
- Provide technical support to Operations to achieve manufacturing quality, productivity, delivery, and throughput objectives.
- Develop technical documentation, test plans, reports, risk assessments, qualifications, work instructions, and other documentation supporting manufacturing processes and engineering decisions.
- Partner with Quality and Operations to ensure processes remain compliant, capable, and controlled.
Continuous Improvement & Lean Manufacturing- Lead cross-functional continuous improvement projects focused on improving yield, quality, productivity, cycle time, cost, throughput, ergonomics, and overall equipment effectiveness.
- Identify process improvement opportunities through data analysis, statistical methods, Gemba observations, value stream analysis, and hands-on interaction with manufacturing processes.
- Lead structured problem-solving activities using tools such as Root Cause Analysis, 5-Why, Fishbone, Pareto analysis, DOE, and other statistical methods.
- Own and execute cost-reduction initiatives across manufacturing operations.
- Lead Lean manufacturing initiatives and transformations within production and supporting areas.
- Develop and implement standardized processes, work methods, and improvements that drive sustainable operational performance.
- Measure and communicate project results, including financial impact, productivity improvements, quality improvements, and capacity gains.
- Utilize project management skills to establish priorities, timelines, resources, and deliverables for engineering initiatives.
Capacity, Automation & Equipment Improvements- Assess current and future manufacturing capacity requirements and reconcile available capacity with business demand.
- Develop capacity improvement strategies and recommendations based on production requirements, process capability, equipment utilization, labor requirements, and operational constraints.
- Identify opportunities to improve capacity through process optimization, equipment upgrades, automation, tooling, fixtures, layout, staffing models, and workflow improvements.
- Specify tooling, fixtures, equipment, and other manufacturing technologies required to meet current and future production needs.
- Support the evaluation and implementation of automation and technology solutions that improve throughput, quality, safety, and efficiency.
- Coordinate the planning, procurement, installation, commissioning, qualification, and implementation of new equipment, tooling, fixtures, and manufacturing technologies.
- Develop capital project justifications and provide technical recommendations for equipment and process investments.
New Product Introduction & Product Transfers- Partner with Product Development Engineering to ensure manufacturability is considered throughout the product development process.
- Provide manufacturing input during product development, including Design for Manufacturing (DFM) considerations, process capability, tooling, equipment, automation, labor requirements, and capacity.
- Support new product introductions and transfers from development into manufacturing, ensuring processes are capable, efficient, scalable, and production-ready.
- Provide input to product development teams based on manufacturing lessons learned and production experience.
- Develop, evaluate, and release manufacturing process documentation for new and modified processes.
- Support PFMEA, DFMEA, process validation, equipment qualification, risk assessments, and other technical activities associated with new product introduction.
- Specify tooling, fixtures, equipment, and manufacturing technologies required to support new product launches and capacity requirements.
- Coordinate the planning, procurement, installation, commissioning, and qualification of equipment and manufacturing processes.
- Develop and execute implementation and qualification plans for new processes and equipment.
- Train Operations personnel on new processes, equipment, tooling, and standardized work.
Required Qualifications- Bachelor's degree in Engineering, preferably Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related discipline.
- Minimum of 5 years of manufacturing engineering experience, preferably within a regulated medical device or highly regulated manufacturing environment.
- Experience supporting production operations in a hands-on manufacturing environment.
- Strong experience with structured problem solving, root cause analysis, and statistical analysis.
- Experience leading continuous improvement and Lean Manufacturing initiatives.
- Training and experience in Lean and Six Sigma methodologies, or equivalent practical experience.
- Working knowledge of ISO 13485, FDA requirements, Design Controls, CAPA, SCAR, and audit processes.
- Experience with Design for Manufacturing (DFM), DFMEA, PFMEA, Design of Experiments (DOE), process validation, and equipment qualification.
- Demonstrated experience managing cross-functional engineering projects from concept through implementation.
- Strong analytical, problem-solving, project management, and communication skills.
- Ability to work effectively on the manufacturing floor and collaborate with employees at all organizational levels.
Preferred Qualifications- Experience in medical device, dental, pharmaceutical, or other regulated manufacturing.
- Experience with automation, robotics, machine vision, or advanced manufacturing technologies.
- Experience with manufacturing capacity modeling, space planning, equipment utilization, and production layout optimization.
- Experience with CNC machining, tooling, fixtures, and process development.
- Experience with statistical software, data visualization, or manufacturing analytics.
- Six Sigma Green Belt or Black Belt certification.
- Experience with ERP/MRP systems and manufacturing performance data.
- Experience leading capital equipment and manufacturing technology projects.
Core Competencies- Technical Leadership: Provides strong technical direction and practical solutions to complex manufacturing challenges.
- Continuous Improvement: Identifies opportunities and translates them into measurable improvements.
- Problem Solving: Uses data, statistics, and structured methodologies to identify root causes and prevent recurrence.
- Operational Excellence: Balances safety, quality, delivery, cost, capacity, and employee ergonomics.
- Collaboration: Builds effective partnerships across Operations, Quality, Maintenance, Product Development, and other functions.
- Project Leadership: Drives initiatives from concept through implementation while managing scope, resources, timelines, and results.
- Hands-On Execution: Comfortable working directly on the manufacturing floor to understand problems and implement solutions.
Why Join Us?This is a high-impact engineering role with the opportunity to influence manufacturing strategy, technology, capacity, and operational performance. The Senior Manufacturing Engineer will play a key role in advancing manufacturing capabilities, supporting new product growth, and driving a culture of continuous improvement and operational excellence.
