Manufacturing Engineer (CM) of Medical Devices
1 day ago
Oceanside
Job Description Position Overview We are seeking a hands-on Manufacturing Engineer to support ongoing production operations and upcoming manufacturing projects. This role is responsible for improving production documentation, process capability, line performance, product quality, and operational excellence. The ideal candidate combines strong analytical and problem-solving skills with a practical, shop-floor approach. You will work closely with Production, Quality, and our Customer’s Manufacturing Engineering team members to improve quality, throughput, capacity, and operator efficiency. Key Responsibilities Production Documentation and Continuous Improvement • Develop, revise, and maintain clear, accurate, and operator-friendly production documentation, including Work Instructions and Device History Records (DHRs)., • Incorporate operator feedback into documentation updates and continuous improvement activities., • Establish effective methods for receiving, evaluating, and implementing operator feedback., • Communicate feedback, recommendations, and resulting actions to Operations, Quality, and other stakeholders., • Identify opportunities to simplify processes, reduce variation, and improve production efficiency. Risk Management and Change Control • Conduct and document formal risk assessments for ongoing production operations and proposed process changes., • Apply a risk-based approach to engineering changes and process improvements., • Develop and maintain Process Failure Modes and Effects Analyses (pFMEAs)., • Ensure risks, mitigations, and verification activities are appropriately documented through the change-control process. Line Performance, Capacity, and Throughput • Perform line-balancing studies to identify bottlenecks, capacity constraints, and throughput limitations., • Evaluate production-line configurations based on:, • Risk of test escapes, • Material flow, • Operator workload, • Cycle-time balance, • Equipment availability, • Throughput targets, • Product and process quality risks, • Quantify, document, and justify recommendations for line configurations and resource requirements., • Assess production capacity ranges and define requirements for scaling beyond current operating targets., • Monitor, analyze, and report key manufacturing metrics, including throughput, yield, scrap, downtime, and cycle time., • Support applicable production processes, including TD2, BSC, and board-level/SMT manufacturing lines., • Conduct downtime analyses and root-cause investigations., • Document findings and develop practical, measurable improvement plans. Process Capability, SPC, and Data Analysis • Define, monitor, and analyze Critical-to-Quality (CTQ) metrics to evaluate product and process variability beyond yield., • Establish and maintain an understanding of process capability and process stability., • Identify key process variables and measurement systems required for Statistical Process Control (SPC)., • Develop appropriate control methods and conduct ongoing analysis of process trends and variability., • Apply statistical techniques to evaluate process performance, identify sources of variation, and support data-driven decisions., • Present technical findings and recommendations clearly to cross-functional stakeholders. Product Quality and Design Feedback • Evaluate products and processes for Design for Manufacturability and Design for Assembly (DFM/DFA)., • Provide structured, actionable feedback that improves manufacturability, assembly efficiency, and product quality., • Collaborate with Customers on design, process, and technical matters., • Maintain a strong understanding of CTQ parameters and apply them throughout product and process evaluations., • Support the transfer of new or updated products and processes into production. Shop-Floor Support and Operational Excellence • Provide direct engineering support to production personnel and resolve shop-floor issues in a timely manner., • Verify that workstations, tooling, equipment, materials, and documentation are appropriately configured for process execution., • Implement, assess, and sustain 6S practices across production areas., • Lead or support daily startup reviews, production meetings, and operator huddles., • Train operators on proper process execution, documentation requirements, and manufacturing best practices., • Build strong working relationships with operators and encourage an open, collaborative improvement in culture. Qualifications • Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Electrical Engineering, or a related technical discipline., • 5+ years of manufacturing engineering experience, preferably in a regulated or high-reliability manufacturing environment., • Experience developing and maintaining Work Instructions, DHRs, pFMEAs, and controlled manufacturing documentation., • Working knowledge of risk management, engineering change control, root-cause analysis, and corrective-action methods., • Experience with production-line balancing, capacity planning, cycle-time analysis, and throughput optimization., • Knowledge of CTQs, SPC, process capability, measurement systems, and statistical data analysis., • Experience supporting SMT, electronics, board-level assembly, or comparable manufacturing processes is preferred., • Familiarity with Lean manufacturing, 6S, DFM/DFA, and continuous improvement principles., • Strong analytical, organizational, and technical communication skills., • Ability to work effectively across Production, Quality, Operations, and R&D teams., • Willingness to spend significant time on the production floor and provide responsive, hands-on engineering support. What Success Looks Like In this role, you will help create stable, scalable, and well-documented manufacturing processes. Your work will lead to clearer production instructions, stronger risk controls, improved process capability, greater throughput, reduced downtime and scrap, and better communication between operators and engineering teams.