MPDE CA Process Design Engineer(Senior Engineer)

Facility Mechanic

MFG & Process Development Engineer II – Molding

Responsibilities: Process Solution Development: <ul><li>Design or optimize production process routes based on product design drawings (e.g., mechanical structures, electrical schematics), including raw material selection, process planning (e.g., cutting, wire pre-treatment, welding, forming, assembly, testing), equipment selection and parameter setting, and DOE development to ensure mass and stable production.</li><li>For new products (e.g., mechanical parts, electronic components), organize DFM reviews within the MPDE department, provide optimization suggestions from a manufacturability perspective, develop trial production process plans, participate in trial production, and resolve process issues (e.g., dimensional deviations, assembly difficulties, inefficiencies).</li></ul> Process Documentation: <ul><li>Prepare standardized process documents, such as SOPs, process flowcharts, PFMEA, and inspection standards, to clarify operational specifications and quality control points for each process, ensuring unified execution by production personnel.</li></ul> Production Efficiency and Quality Optimization: <ul><li>Analyze existing production processes, use lean production tools (e.g., 5S, value stream analysis) or technical improvements (e.g., introduction of automated equipment, process consolidation) to reduce production costs, shorten cycle times, and enhance capacity.</li><li>Collaborate with the quality department to investigate the causes of quality anomalies (e.g., excessive defect rates) from a process perspective (e.g., insufficient equipment precision, unreasonable process parameters), develop improvement measures, and validate their effectiveness through DOE.</li></ul> Cross-Department Collaboration: <ul><li>Work with R&amp;D departments, participate in product design reviews, provide suggestions from a process feasibility perspective (e.g., simplifying structures to reduce assembly difficulty), and promote Design for Manufacturability (DFM).</li><li>Communicate with supply chain departments to confirm the process compatibility of raw materials and assist in resolving process-related issues with purchased materials. Cooperate with production departments to train operators on new processes and equipment, ensuring successful implementation.</li><li>Collaborate closely with automation teams, participate in automation solution reviews, and develop validation methods.</li></ul> Technological Innovation and Cost Reduction: <ul><li>Stay updated on industry advancements (e.g., 3D printing, smart inspection equipment, laser welding), evaluate their applicability to existing production, and drive process upgrades. Achieve cost reduction through process optimization and the use of alternative low-cost materials (without compromising quality).</li></ul> Requirements: Education and Major: <ul><li>Bachelor’s degree or higher in Mechanical Engineering, Materials Science and Engineering, Industrial Engineering, Electrical Automation, or related fields.</li></ul> Knowledge and Skills: <ul><li>Mastery of fundamental manufacturing process principles (e.g., machining, electronic assembly, heat treatment) and familiarity with production processes in at least one industry (e.g., automotive parts, electronic devices, machinery manufacturing).</li><li>Strong process analysis skills, ability to interpret drawings using CAD/SolidWorks, and perform data analysis with tools like Minitab (e.g., analyzing defect rate causes).</li><li>Knowledge of quality and efficiency improvement methods such as Lean Production and Six Sigma; prior experience in process optimization projects is preferred.</li></ul> Experience Requirements: <ul><li>Typically requires 5+ years of experience in process development or production technical support in relevant industries; familiarity with high-speed cable equipment and process requirements is preferred.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Responsibilities: <ul><li>Overall molding process development, coordinating with interaction processes (Stamping, Plating, Assembly) to ensure the best process and cost for F/Gs</li><li>Concept design &amp; proofing for Molding process and tooling, Process development DOE.</li><li>Technical leader and trouble shooter from LVM to HVM in process development, tooling design &amp; qualification, issue finding and problem solving</li><li>Platforming manufacturing process development.</li><li>Challenge product design for manufacturability and cost feasibility.</li><li>Launch product at rate through FACA/QCPA tools (yield, CPK, OEE…)</li><li>Launch product on time with cross function team.</li><li>Process documentation (DFM，FMEAs, WI, FACA/QCPC…)</li></ul> Requirements:﻿ <ul><li>Bachelor or above degree in mechanical engineering or related background.</li><li>5+ years Mold design, Process and Troubleshooting knowledge / experience.</li><li>Strong knowledge of tool fabrication, tool-steel application/selection, heat treating, and plating/coating.&nbsp;</li><li>Strong knowledge of injection molding processes (Injection, Insert-molding, two-shot, etc.).</li><li>Strong understanding of plastic, injection machine, auxiliary equipment (strip feed, camera, etc).</li><li>Good at Mold flow simulation and analysis.</li><li>Familiar with BTI 5-Step process, and Knowledge of SIM (Scientific Injection Molding).</li><li>Understand tolerance calculations and Geometric Dimensioning and Tolerancing.</li><li>Data oriented issue finding and problem-solving skills.</li><li>Rich shopfloor hand on experience.</li><li>Sensitive on product cost, know how to drive cost through manufacturing process development &amp; design optimization.</li><li>Fluent in using of basic process development related tools like DFM, PFMEA，DOE，FAA, CTAR，CAD，Pro E</li><li>Knowledge of quality control and quality issue analysis and improvement</li><li>Good teamwork and communication skills。</li><li>Fluent in written and Spoken English.</li><li>Oversea working experience is a plus</li></ul>

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MPDE CA Process Design Engineer(Senior Engineer)

Facility Mechanic

MFG & Process Development Engineer II – Molding

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MPDE CA Process Design Engineer(Senior Engineer)

Facility Mechanic

MFG & Process Development Engineer II – Molding

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