Manufacturing Engineer II

Location: San Jose, CA • Duration: 12 months • Pay rate: $20–30/hr • Schedule: 1st shift, 8:00 AM–5:00 PM, 40 hours/week • Employment type: W2 contract (US citizens or Green Card holders only)

About the role

The Manufacturing Engineer II (ME II) is a key contributor within the Instruments Manufacturing department, responsible for both manufacturing engineering and project management on projects or problems of small to moderate scope. The role requires good judgment with minimal management oversight, the ability to lead change, contribute new ideas, and find innovative methods to accomplish goals. The ME II must effectively collaborate with individuals who do not report directly to them.

Responsibilities

• Serve as a key member or lead of cross-functional project teams in Manufacturing Operations to improve operational efficiency, optimize product design, qualify replacement components or suppliers, enhance product quality, improve customer satisfaction, or reduce manufacturing and material costs.
• Support the introduction of new products into manufacturing as part of an NPI (New Product Introduction) program team.
• Establish processes and procedures, create assembly documentation, and review engineering designs for completeness, clarity, and manufacturability.
• Evaluate and qualify new suppliers and train production personnel.
• Mentor and oversee more junior engineers.
• Create and understand engineering drawings, Bills of Materials (BOMs), routings, Cost of Goods Sold (COGS), and operational procedures.
• Author Engineering Change Orders (ECOs) and implement them into the operational and commercial environment.
• Provide hands-on support to manufacturing assembly and test processes for flow cytometry instruments.
• Determine root cause of complex technical issues and implement effective solutions in a timely manner.
• Incorporate Design-for-Manufacturability (DFM) and Lean Manufacturing concepts into product and process design.
• Develop and execute defendable Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) protocols to test and qualify new components, tools, or process steps. Update Approved Manufacturer Lists (AMLs) and Approved Supplier Lists (ASLs) in collaboration with internal teams and external suppliers.
• Perform and document field failure investigations, identify root cause, and participate in corrective and preventive action efforts.
• Maintain compliance with regulatory requirements in own area of work, including training on relevant issues and escalating concerns to management.
• Promote a safe work environment, participate in Environmental, Health, and Safety (EHS) programs, and address corrective actions for identified hazards.

Requirements

• Bachelor’s degree in Mechanical Engineering (ME), Electrical Engineering (EE), Industrial Engineering (IE), Information Technology (IT), or equivalent.
• 4–6+ years of experience in a high-tech manufacturing environment.
• Proficiency in Microsoft Windows tools, including MS Project and Visio.
• Excellent written and verbal communication skills, with strong interpersonal abilities in conflict resolution, negotiation, and time management.
• Experience with engineering drawings, Bills of Materials (BOMs), and operational procedures.
• Experience writing and reviewing Engineering Change Orders (ECOs).
• Project management experience, including leading continuous improvement efforts with cross-functional teams.
• Experience developing manufacturing processes, writing procedures, and training assembly personnel.
• Ability to work with quality and reliability teams to conduct risk analyses, Failure Mode and Effects Analysis (FMEA) reviews, and define critical-to-quality criteria.
• Ability to work effectively with minimal direction and proactively address problems.
• Familiarity with ISO 9000 standards.
• Proficiency in SolidWorks (required).
• Experience in medical device or complex systems manufacturing (required).
• Experience with BOMs, routings, manufacturing assembly documentation, and tooling development (required).

Desirable Qualifications

• Proficiency with Creo/Pro-E, AutoCAD, MS Access, or SAP ERP.
• Experience resolving technical issues involving lasers, optical components, fluidic systems, or digital/analog circuitry.
• Experience supporting commodities or supplier types such as lasers, optical components, fluidic systems, machined parts, sheet metal, cables, printed circuit assemblies (PCAs), plastics, power systems, product packaging, turnkey subcontractors, hardware, or labeling.
• Familiarity with cGMP (21 CFR Part 820) and medical device manufacturing experience.
• Experience implementing Demand Flow Technology (DFT) or Lean manufacturing processes.
• Experience utilizing Design-for-Manufacturability (DFM) concepts.
• Six Sigma Green or Black Belt certification.