Manufacturing Engineer

Client: Medical Devices Company Position: Manufacturing Engineer (Mid-Level or Senior Level). Employment Type: Contract on W2 (US Citizens or GC Holders Only). Duration: 12 months. Location: San Jose, CA. Work Hours: 8AM-5PM. Must Haves On The Resume Proficient with SolidWorks, Oscilloscope, and Engineering Change Orders Familiar with ERP SAP system, Agile or similar, and electro‑mechanical assemblies – PCBAs & sheet metal experience with troubleshooting of instrumentation devices Experience in the medical/ pharmaceutical industry Job Description The Senior Manufacturing Engineer will lead multiple high‑impact projects, devise innovative methods to accomplish goals, and solve complex mechanical/electrical/electronic problems. Works independently, exercises judgment, and may supervise others. Determine methods and procedures for new assignments and get things done through people who do not report to them. Work through adverse situations while building and maintaining good personal relationships. Responsibilities Initiate, plan, and author engineering change orders for product design, documentation, bill of materials, manufacturing/test/packaging procedures, process routings, tooling, compliance (EMC, safety, laser safety, RoHS, UDI, etc.), suppliers, and other items in a controlled manufacturing environment. Follow proper document formats, material and description nomenclature, and correct SAP data types per company standards. Coordinate with various functions for change review and impact analysis, ensuring cross‑functional requirements are identified and understood for affected items, personnel, and processes. Lead cross‑functional project teams to optimize product design, qualify replacement components, improve manufacturing operational efficiency, product quality, customer satisfaction, and reduce manufacturing costs. Capable of solving and determining root cause of difficult technical issues encountered during assembly and test of production assemblies. Implement effective solutions in a timely manner to resolve mechanical, optical, electrical, and fluidic issues. Support the introduction and transfer of new products into manufacturing. Review engineering designs and documentation (drawings & specifications) for completeness, clarity, and manufacturability. Evaluate and qualify new suppliers. Interface with Product Development to define and implement manufacturability criteria, develop procedures/processes for assembly, PCBs, systems, and sub‑systems test procedures including fixtures during the development process. Ensure designs, documents, and procedures have been validated in manufacturing prior to production release. Conduct field failure investigations, identify root causes, and participate in corrective and preventative action efforts. Keep abreast of the basic requirements for compliance. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management. Perform other related duties and assignments as required. Qualifications BS degree: Mechanical Engineering, Electrical Engineering, Industrial Engineering, Physics, or equivalent. At least 4 years of experience in a high‑tech manufacturing environment. Experience sustaining and troubleshooting electro‑mechanical devices/equipment. Proficient in the use of personal computers: SolidWorks (CAD), MS Office (Word, Excel, PowerPoint, Project, Visio), Adobe. Familiar with ERP SAP, Agile or similar. Excellent written and verbal communication skills, with strong interpersonal skills: conflict resolution, negotiation, and time‑management skills. Ability to understand engineering drawings, bills of materials, and operational procedures. Extensive experience writing and reviewing Engineering Change Orders. Strong project management experience; led continuous improvement efforts with cross‑functional teams. Experience developing manufacturing processes, writing procedures, and training assembly personnel. Ability to assess and resolve multiple high‑visibility problems in a timely manner. Ability to successfully interact with executive management. Effective with minimal direction. Recognizes problems and addresses them without waiting for instruction. Familiarity with ISO 9001 and ISO 13485 standards. Willingness to travel when required. Preferred Skills And Qualifications MS degree. Proficiency with Pro‑E, AutoCAD. Experience resolving technical issues involving lasers and optical components. Broad experience supporting many commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCAs, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling. Strong cGMP familiarity (21 CFR Part 820); medical industry experience. Experience implementing Demand Flow Technology (DFT) processes. Experience implementing Lean manufacturing processes. Six Sigma green or black belt. #J-18808-Ljbffr MillenniumSoft Inc