Manufacturing Process Engineer

4 days ago

San Jose, California, United States MILLENNIUMSOFT Full time
Job Description:

At MillenniumSoft, we are seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our engineering team, you will be responsible for leading multiple high-impact projects simultaneously, driving change, and contributing new ideas to improve manufacturing operations.

Key Responsibilities:

  • Lead cross-functional project teams to improve manufacturing operational efficiency, optimize product design, and qualify replacement components.
  • Develop and implement effective solutions to complex technical issues, often involving multiple disciplines such as mechanical, optical, electrical, and fluidic systems.
  • Support the introduction of new products into manufacturing, reviewing engineering designs and documentation for completeness, clarity, and manufacturability.
  • Interface with Product Development to define and implement manufacturability criteria, develop procedures for assembly, PCB testing, and system testing.
  • Ensure designs, documents, and procedures have been validated in manufacturing prior to production release.
  • Assess feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data is insufficient or confirmation by testing is advisable.
  • Work independently with general instructions, receiving technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
  • Perform and document field failure investigations, identify root causes, and participate in corrective and preventive action efforts.
  • Promote a safe work environment, provide recommendations on maintaining safety, and participate in Environmental, Health, and Safety programs.

Requirements:

  • Typically requires a BS degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Physics, or equivalent.
  • 8+ years of experience in a high-tech manufacturing environment.
  • Proficient in MS Office, MS Project, Visio, and Windows or MAC OS.
  • Excellent written and verbal communication skills, with good interpersonal skills, conflict resolution, negotiation, and time management skills.
  • Ability to understand engineering drawings, Bills of Materials, and operational procedures.
  • Experience writing and reviewing Engineering Change Orders, developing manufacturing processes, and training assembly personnel.
  • Strong project management experience, led continuous improvement efforts with cross-functional teams.
  • Ability to assess and resolve multiple high-visibility problems in a timely manner.
  • Familiarity with ISO 9001 and 13485 standards.
  • Willingness to travel frequently.

Desirable Qualifications:

  • M.S. degree.
  • Proficiency with Pro-E, AutoCAD, Solidworks, MS Project, MS Access, SAP ERP, and Visio.
  • Experience resolving technical issues involving lasers and optical components.
  • Broad experience supporting commodities or supplier types such as lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA's, plastics, power systems, product packaging, turnkey subcontractors, hardware, and labeling.
  • Strong cGMP familiarity 21 CFR part 820, medical industry experience.
  • Experience implementing Demand Flow Technology (DFT) processes and LEAN manufacturing processes.
  • 6 Sigma green or black belt.

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