The Manager-Product Engineer (Medical Products) role serves as the primary link between manufacturing and the customer, ensuring compliance with customer quality and regulatory requirements, as well as meeting all product specifications and expectations. Led the Engineering Department comprising 15 subordinates, overseeing NPI, Product, Process, CIM/CAM, and Label engineering teams. Directed activities to determine BOM structure and develop Process FMEA, Product Control Plan, APQP, ABIs, and tooling strategy. Significant improvement achieved in addressing low volume solder issues for a critical medical product, resulting in a nearly 30% reduction in defect rates. Achieved a 5% improvement in Post Quality yield for another medical product by collaborating with the team to address and resolve quality issues. Led the team to successfully complete readiness and build phases for multiple NPI projects, navigating challenges such as high turnover and tight timelines, including coordinating day and night calls as necessary. Act as the technical expert for customer and internal manufacturing inquiries, facilitate design for manufacturability discussions, leading immediate analysis and resolution of product-related issues by coordinating subject matter expert (SME) assistance when required. Lead initiatives at the product level aimed at improving efficiency and effectiveness. Collaborate on identifying root causes of failures and develop comprehensive short- and long-term action plans for Corrective and Preventive Actions (CAPA). The leader is responsible for embodying and ensuring adherence to Plexus Core Values within their team. They will prioritize assessing potential, driving succession planning, and ensuring that employees receive the necessary development and coaching to maximize their capabilities.

Led and managed the Engineering Department, overseeing a team of 14 subordinates encompassing NPI, Product, Process, and Test engineering staff, to support the company's strategic and financial objectives. Developed an engineering technology roadmap to provide the engineering team with long-term vision and guide future direction. Achieved a reduction in quotation submission time to customers from 5 to 3 working days, while consistently meeting 100% of product launch schedules. Implemented streamlined processes and standardized tools, resulting in a reduction of manufacturing cycle time and an improvement in units per hour (UPH) by 20%. Through continuous process improvements and ongoing cost reduction initiatives, successfully contributed to meeting company revenue goals. Increased the operation yield of engineering and manufacturing staff by addressing critical technical and program issues through upgraded engineering structures, operating procedures, and automated/semi-automated tools and fixtures. Proficient in ISO 13485:2016 standards and adept in executing Medical Manufacturing Process Validation Plans, ensuring adherence to proper Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

Total subordinates include 1 Quality Engineer and 2 Quality Technicians. Effectively established RMA (Return Merchandise Authorization) and quality procedures and processes to ensure proper containment and disposition of defective drives. Identified and improved RMA process gaps by implementing CAMSTAR & SAP system controls through continuous improvement efforts. Reduced the disposition lead time for RMA defective drives in Non-Nett Location from 7 working days to 4 working days. Became IMS internal auditor and coordinator for the QA team, achieving zero non-compliance findings during IMS audits. Collaborated with customers and manufacturing personnel to address customer complaints through thorough 8D reports, incorporating root cause analysis and implementing Poka Yoke solutions as necessary. Developed QA metrics and data analysis tools to effectively measure and monitor package quality.

Total subordinates include 2 Technicians (Product and Process). Received the Best Staff Award in 2015 by leading software, production, and quality teams for improving ESG rework yield efficiency from 58% to 65%. Successfully established and transferred product and process technical knowledge to Seagate's suppliers in Greystone Vietnam and UPS Brazil. As a committee member, contributed to the company's achievement of becoming the first to obtain ISO 28000:2007 certification from SIRIM in Penang. Coordinate weekly conference calls to present ECR (Engineering Change Request), NPI (New Product Introduction), and process yield reports to customers. Implement innovative use of new analytical tools, equipment, and methodologies to drive product and process improvements. Study and analyze BOM, implement ECR, and develop SOPs and product manuals in accordance with document control requirements.

Coordinated with US counterparts and worked with vendors to submit the first engineering lot of Orthopaedics medical case to the customer. Achieved annual cost savings of 5% through effective cost reduction initiatives with the medical case vendor. Developed and executed project activities including project planning, scheduling, kick-off meetings, client management documentation, and all aspects of project control. Negotiated and communicated with both internal teams and external customers regarding pricing and engineering issues. Designed and developed quality plans, test methods, inspection jigs, and fixtures for various parts in collaboration with Engineering and Quality Assurance, within a high mix, low volume environment. Established and maintained positive relationships with customers and vendors, fostering win-win situations for all parties involved.