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Sr. Manufacturing Engineer
Ref No.: 18-28263
Location: Irwindale, California
Position Type:Full Time/Contract
Experience Level: 5 Years
Start Date: 04/24/2018
The Sr. Manufacturing Engineer plans and oversees the execution of manufacturing process development for NPD, engineering change requests, product sustaining, and continuous improvement.  S/he will collaborate with contract manufacturers (CMs) and upstream suppliers, as well as company's cross-functional teams to design, develop, and drive improvements to product DFM, manufacturing system, quality, reliability, cost and output.
Roles and Responsibilities:
  • Perform as a bridge between internal product development team and external suppliers to communicate technical matters.
  • Design, document, assemble, qualify and introduces production assembly/test/inspection fixtures and equipment.
  • Proficient in reading and creating mechanical drawings.
  • Takes ownership of products during product transfer phase through successful and sustained project launch. This includes driving schedules, resolving manufacturability issues, and driving improvements for cost and efficiency.
  • Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering to enhance manufacturability and product cost.
  • Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, work flow processes and detailed work instructions.
  • Modifies BOM's, work instructions, and process flow diagrams by ECO writing and implementation as requested by R & D or NPD.
  • Designs and creates production equipment, fixtures and tests as needed to build the production line either internally or at suppliers.
  • Provides training and support to production technicians.
  • Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions.
  • Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
  • Leads/participates in continuous improvement initiatives focused on material cost reduction and capacity enhancement.
  • Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
  • Building the manufacturing line could either be internal or external at a supplier.
  • Supports, maintains, improves modifies and further develops the manufacturing line as needed for sustaining production.
  • Other reasonable assigned duties.
Skill/Job Requirements:
  • 4-year degree in Mechanical or Industrial Engineering.
  • 5+ years of experience as manufacturing engineer supporting product with medical device content.
  • Demonstrated understanding of manufacturing processes including precision mechanical assembly, testing, troubleshooting and rework.
  • Demonstrated knowledge of inspection processes and Lean principles.
  • New product development experience.
  • CAD experience (Solid Works preferred).
  • Strong problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
  • Excellent communication, organization, follow-up and documentation skills.
  • Comfortable interacting with technicians, engineers, and management all on a regular basis.
  • Strong technical skills in prototyping, tooling development and troubleshooting.
  • Experience in medical device manufacturing environment.
  • Able to work in both US and China with up to 50% travel
  • Fluent in English but bilingual Mandarin (a plus)