Manufacturing Engineer

Position SummaryThe Manufacturing Engineer is responsible for developing, maintaining, and improving manufacturing processes across the full production lifecycle, from receipt of materials and component preparation through manufacturing, assembly, inspection, packaging, and release. The role provides hands-on engineering support for new product introduction, established production, engineering changes, and equipment and process improvements. Working with Operations, Quality, Maintenance, Automation, Supply Chain, and Process Engineering, the Manufacturing Engineer ensures processes are safe, capable, efficient, documented, validated, and compliant with applicable medical device requirements. Roles and ResponsibilitiesProduction Process Ownership and Support Own and support the end-to-end manufacturing process, including material flow, equipment setup, processing, assembly, inspection, test, packaging, and transfer of completed product to the next operation or release process. Maintain a thorough understanding of process inputs, outputs, critical process parameters, quality characteristics, acceptance criteria, and interactions between operations. Provide floor-level engineering support to resolve production issues in volving equipment, tooling, fixtures, materials, methods, automation, documentation, and operator workflow. Partner with Operations and Maintenance to reduce downtime, recurring equipment failures, process interruptions, and production constraints. Develop and maintain process flow diagrams, value stream maps, line layouts, standard work, capacity models, and manufacturing readiness assessments. Support production planning and capacity decisions by evaluating equipment capability, staffing assumptions, tooling needs, bottlenecks, and demand requirements. Ensure manufacturing processes remain in a validated and controlled state throughout routine production. Monitor and report manufacturing KPIs, including quality, yield, scrap, cycle time, production rate, downtime, capacity, and fulfillment. New Product Introduction and Cross-Functional Support Support design transfer and new product introduction from manufacturing concept through validated commercial production. Provide design-for-manufacturability input and identify production risks, equipment needs, tooling requirements, inspection methods, training needs, and capacity requirements. Support pilot builds, production trials, ramp-up activities, and transfer to the ultimate manufacturing site. Collaborate with customers and cross-functional teams regarding process capability, production issues, deviations, engineering changes, and improvement activities. Engineering Changes and Process Improvement Initiate, assess, and implement Engineering Change Orders (ECOs) affecting materials, components, tooling, equipment, software, automation, process parameters, inspection methods, and manufacturing documentation. Evaluate the production, quality, validation, training, inventory, supplier, and regulatory impact of proposed engineering changes before implementation. Develop implementation plans for changes, including document updates, risk reviews, validation or verification activities, training, material disposition, and effective-date coordination. Use structured problem-solving methods such as 5 Why, Fishbone, DMAIC, and data analysis to investigate deviations, nonconformances, equipment issues, and recurring process failures. Support CAPA investigations and implement sustainable corrective and preventive actions within manufacturing. Lead or support continuous improvement activities using Lean Manufacturing, value stream mapping, mistake-proofing, and waste-reduction methods. Confirm that completed improvements achieve the intended results through follow-up monitoring of process performance and quality data. Equipment, Tooling, Automation, and Validation Define requirements for manufacturing equipment, molds, tooling, fixtures, gauges, automation, and supporting utilities. Coordinate equipment and tooling activities with internal departments, outside suppliers, and consultants to meet technical, cost, and schedule requirements. Support equipment installation, startup, commissioning, and transfer into production. Develop and execute equipment qualifications and process validations, including MVP, IQ, OQ, and PQ, as applicable. Support test method validation and measurement system analysis, including Gauge R&R. Apply statistical methods such as p-values, capability analysis, Cpk, Ppk, control charts, and data transformation to evaluate process performance and validation results. Support preventive maintenance strategies, spare-parts planning, calibration requirements, and controls needed to sustain reliable production. Manufacturing Documentation and Systems Create, revise, and maintain controlled manufacturing documentation, including: Manufacturing Instructions and Work Instructions Bills of Materials (BOM) Device Master Records (DMR) Device History Record requirements (DHR) Process Flow Diagrams and line layouts Control Plans Ensure documentation accurately reflects the approved production process and is updated before or concurrent with implementation of changes. Maintain working knowledge of MES, LIMS, ERP, EAM, and document control systems used to manage production, quality, maintenance, materials, and records. Support operator and technician training associated with new or revised processes, equipment, and documentation. Required Education, Experience, Skills, and KnowledgeBachelor’s degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or an equivalent engineering discipline. Five or more years of manufacturing engineering experience in medical device manufacturing, plastic injection molding, automated assembly, or a comparable regulated manufacturing environment is preferred. Hands-on experience supporting routine production processes, troubleshooting manufacturing equipment, and implementing process improvements. Experience with engineering change control, controlled documentation, risk assessment, validation, nonconformance investigation, and CAPA support. Knowledge of Lean Manufacturing, value stream mapping, standard work, and continuous improvement methodologies. Experience with process capability, statistical analysis, measurement system analysis, and data-based problem solving. Experience with manufacturing equipment, automation, tooling, fixtures, and production line development is preferred. Solid knowledge of GMP, 21 CFR Part 820, ISO 13485, and applicable quality system requirements. Strong computer skills, including Microsoft Office, ERP, MES, EAM, and document control systems. Ability to read, write, and speak fluent English, with strong written and verbal communication skills. Ability to prioritize and manage multiple production, improvement, and project deliverables in a fast-paced environment. Strong problem-solving and critical-thinking skills; self-directed, detail-oriented, and comfortable working on the production floor. Ability to work independently and collaboratively across Operations, Quality, Maintenance, Automation, Supply Chain, and Engineering.