Demo

Senior Manufacturing Engineer

Staff Works
Poway, CA Full Time
POSTED ON 4/24/2025
AVAILABLE BEFORE 5/21/2025

Duties :

  • Provide technical support to help manage change and troubleshoot problems. Support with coaching other engineers on problem solving and project management.
  • Design and improve existing tooling and equipment used in production and validate such equipment using standard medical device industry techniques.
  • Work in collaboration with the NPI engineering group to support the transfer of new technologies and products from Development to Production.
  • Lead the development, improvement, and strategy of the area(s) in which incumbent is accountable for. Own key site metrics related to accountable areas on site scorecard.
  • May oversee and lead work of other Engineers.
  • Applies Lean principles to drive process improvements across various departments and supports ongoing Kaizen / Process improvement projects.
  • Develops capital equipment justifications for new machines or processes technologies that will support site goals of increasing quality, cost, and / or cycle time.
  • Manages capital equipment projects, including budgetary responsibilities, equipment validation (IQ / OQ / PQ), and effective transfer to production.
  • Comprehends Quality Policy and Quality Objectives. Be knowledgeable of Quality Operating Procedures and functions of the Quality Management System pertaining to this position as determined by the Quality Manager. Commits to complying with ISO-related requirements.
  • Participates in local programs and initiatives to sustain and improve EHS performance.
  • Identifies and validates appropriate metrology tools and inspection techniques for determining product conformance following measurement system analysis (MSA) protocol.
  • Characterizes, optimizes and validates equipment and processes based on statistical experimentation.
  • May travel 20% of the time based on projects assigned.

Qualifications :

  • 4-year degree in relevant engineering-based subject
  • Minimum 5 years’ experience in a manufacturing environment preferably servicing the Medical Device Industry.
  • Working knowledge in Lean Manufacturing and Six Sigma.
  • Ability to operate machinery such as : bench grinder, mill, lathe, laser or other related manufacturing machinery
  • Proficient in Minitab or other statistical software, CAD / CAM (Solidworks, MasterCam, & Esprit preferred)
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