Senior Manufacturing Engineer

Role Purpose The Senior Manufacturing Engineer is responsible for leading advanced process engineering activities across molding and/or assembly operations. This includes ownership of process capability and stability, leading validation and change implementation for assigned scope, driving yield/cost improvement projects, and providing technical leadership to resolve high-impact issues. The role ensures production performance meets quality, cost, and delivery targets while complying with regulatory and safety requirements. You will report directly to the Manufacturing Engineering Lead and work in close collaboration with cross-functional stakeholders. You will act as a technical escalation point for complex issues within your assigned process/area scope. Key Responsibilities Process Engineering & Support • Serve as the technical escalation point for complex molding/assembly / automation process issues, leading structured troubleshooting and containment actions for assigned areas. • Apply scientific molding and advanced process control methodologies to optimize stability, reduce variation, and improve capability (Cp/Cpk). • Lead root cause investigations using robust problem-solving tools (e.g., 8D, DMAIC), and support CAPA effectiveness with measurable results. • Define and maintain process parameters, process windows, and control strategies; ensure process controls are robust and audit-ready within assigned scope. • Lead mold/tooling trials and technical evaluations; provide technical recommendations to improve manufacturability and throughput. Validation, Change Management & Risk Control • Lead and coordinate validation activities (IQ/OQ/PQ) for assigned scope, including protocol drafting/support, execution, and report preparation in accordance with site procedures. • Own Engineering Change Notifications (ECN) for assigned processes/products, including impact assessment, risk evaluation (FMEA), and implementation planning to ensure smooth transition. • Maintain and improve documentation such as control plans, PFMEA, work instructions, and process specifications to reflect latest standards and product changes. • Provide technical input to MRB disposition support, deviation investigations, and product/process risk assessments. Continuous Improvement & Operational Impact • Lead improvement projects to enhance yield, reduce scrap/rework, improve cycle time, and raise OEE for assigned area/process. • Drive lean manufacturing, 6S, Kaizen, and automation initiatives with clear problem definition, data analysis, and measurable results. • Collaborate with Business Excellence to establish data-driven monitoring and structured improvement routines. • Support standardization and replication of best practices through technical documentation and cross-area sharing where applicable. Compliance & Audit Support • Ensure engineering activities comply with ISO 13485, FDA QSR, and internal quality system requirements. • Support customer audits, internal audits, and engineering reviews by preparing technical evidence and closing findings related to assigned engineering scope. • Ensure process validation, change controls, and engineering records are maintained accurately, traceably, and in an audit-ready state. Customer & Stakeholder Management • Support technical communication with customers on process topics, product changes, technical clarifications, and improvement actions related to assigned scope. • Review customer change requests/specifications, assess manufacturability and risk impact, and drive internal actions for lifecycle improvement within assigned area. • Work with suppliers on process/tooling/automation improvements, technical troubleshooting, and corrective actions as required. Reporting & Analytics • Monitor process KPIs and capability metrics; identify trends, risks, and improvement opportunities using statistical tools and structured analysis. • Prepare technical updates and project results for cross-functional stakeholders and leadership reviews. • Maintain consistent technical reporting (e.g., capability studies, validation summaries, scrap Pareto, defect mode analysis) for assigned scope.