Sustaining Manufacturing Engineer

Peak Technical Staffing USA in San Leandro, CA

  • Industry: Engineering - Industrial Engineer
  • Type: Full Time
  • Compensation: $106,650.00 - 158,660.00 / Year*
position filled

You will:

  • Report to the Manufacturing Engineering Director and work closely with the Engineering/R&D, Quality, and Manufacturing/Production Teams.
  • Sustain current production, while having opportunity to transfer new products from development to commercialization.
  • Support supply chain and quality group to resolve part quality issues.
  • Determine root cause analysis, corrective actions and create SCARS.
  • Recommend and implement vetted solutions.
  • Active participant of the Materials Review Board.
  • Drive First Article Inspection (FAI) and Cpk processes in qualification of component level parts and sub-assemblies.
  • Write and execute protocols and corresponding reports for process validations.
  • Create, modify, and release manufacturing process instructions.
  • Perform process time studies and determine equipment utilization rates.
  • Other sustaining engineering tasks as needed.


Job Requirements:

REQUIRED SKILLS AND EXPERIENCE:

  • Desire 5+ years of experience developing, analyzing and supporting high volume manufacturing processes, tooling, fixtures, and mechanisms.
  • Must have medical device experience to include sterile packaging, validations, and verification's.
  • Familiar with GMP and ISO 13485.
  • Experience in mechanical design, materials, analysis, and manufacturing is required.
  • Experience writing IQ/OQ/PQ and process validation documents is required.
  • Proven track record optimizing manufacturing processes.
  • Ability to write clear, illustrated manufacturing and inspection procedures.
  • Machining & use of standard hand and power tools is desired.
  • Working well in teams and independently.
  • Ability to work and communicate effectively with people from all levels of the organization.
  • Must be flexible and willing to perform other tasks as assigned.

Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain

* Estimated salary


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