Jobs at SMC Ltd

Supports medical manufacturing projects from quotation through mold, equipment, and process development, validation, pilot builds, customer approval, and transfer to manufacturing. Designs and reviews molds, tooling, automation, fixtures, and manufacturing processes; develops timelines; manages quality and financial deliverables; conducts testing and DOE; resolves technical issues; prepares validation documentation and Device Master Records; and provides post-release manufacturing support.

Supervises the Automation team while developing, maintaining, and improving automation processes and equipment. Leads new program development, delivers cost-effective solutions, supports manufacturing operations, ensures quality and safety compliance, and manages cross-functional projects. Responsibilities include task assignment, prioritization, technical support, budgeting, cost justification, team development, performance reviews, and implementation of new technologies. The role may require travel to support customer needs.

Administer the LMS (course creation, enrollment, tracking, reporting) and support QMS compliance by planning and leading internal audits, coordinating auditor training, and managing CAPA and complaint processes to ensure timely investigation, resolution, and continuous improvement.

Lead molding-room floor personnel while ensuring safety, compliance, productivity, quality, cleanliness, and scheduled delivery. Set up and troubleshoot assembly, packaging, and testing equipment for medical-device production; train employees; monitor production, scrap, inventory, and traceability; support CAPA, continuous improvement, and 6S Lean activities; maintain standard work instructions; and coordinate with quality, scheduling, customer service, and other departments.

Support new project development and sustain production programs by improving manufacturing methods, troubleshooting equipment, performing validations (IQ/OQ/PQ), training staff, analyzing production data, and leading continuous improvement. Majority of time on the production floor with up to 50% travel to vendors.

Lead production shift activities by assigning tasks, organizing breaks, monitoring work center performance, verifying OMS and work orders, ensuring line clearance and documentation accuracy, and supporting quality, safety, and efficiency on the manufacturing floor.

Operate CNC sink EDM machines to machine cores, cavities and other components to drawing specifications; plan fixtures, design electrodes and select spark gaps/processes; perform EDM to dimensional and surface-finish requirements; use metrology tools for inspection and report machine utilization.

Lead quality engineering for medical device new product development: create pFMEAs, control plans, PPAP, validation protocols; analyze FAIRs and validation data; lead CAPA and customer complaints; manage ECOs and quality documentation; support audits, training, and cross-functional continuous improvement to ensure compliance with ISO 13485 and 21 CFR Part 820.

Support product quality and compliance for medical-device manufacturing: perform incoming/in-process/final inspections, testing, DHR/DMR documentation, calibration and metrology activities, validations (IQ/OQ/PQ), statistical studies, root-cause investigations, and supplier CAPA/8D management per ISO 13485/9001.

Strategic, hands-on HR partner for multi-site operations. Lead employee relations, compliance, talent management, performance and compensation programs; supervise and develop HR staff; manage workers' compensation and OSHA compliance; analyze HR metrics and drive engagement and retention initiatives.

Drive market planning, business development, and customer relationship activities. Prepare presentations, quotations, and sales documentation; support trade shows, invoicing, dispatch, and QMS updates. Collaborate with internal teams, visit customers and plants for technical support, and maintain quote/order logs.

Lead development of new medical device manufacturing projects from quotation through mold/tooling design, process development, validation, and transfer to production. Manage timelines, customer deliverables, testing/DOE, validation reports, and Device Master Record (DMR) creation. Provide technical support post-release and ensure compliance with engineering standards, safety, and quality requirements.

Perform assembly and production tasks on assigned weekday shifts in a medical manufacturing facility. Follow oral and written instructions, perform counting and basic math, communicate in English, work effectively in teams, and operate with minimal supervision. High school diploma and at least one year production experience required; assembly/medical manufacturing experience preferred.

Lead and implement Lean and continuous improvement initiatives across manufacturing (molding) to improve efficiency, quality, and productivity. Drive Kaizen events, value stream mapping, standard work, root cause analysis, KPI monitoring (OEE, yield, cycle time), NPI support, training, and cross-functional project leadership using Lean, Six Sigma, and data analysis.