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Sr. Mfg Engineer

2 months ago

Lawrence, United States EdgeTech Staffing Full time
Advanced Mfg Engineer - Direct - Lawrence, MA -
RESPONSIBILITIES:
  • Lead Process Development and Process Validation activities related Disposable and Hardware production.
  • Specify, select, design, and install of Equipment, Tooling, and Fixtures used in Production.
  • Develop and execute IQ/OQ/PQ protocols and reports.
  • Develop process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), and Statistical Process Control (SPC) techniques.
  • Develop and define concepts and manufacturing processes for, and as an integral part of, all new product and product enhancement programs, using advanced engineering techniques such as DFM / DFA (Design for Manufacturability and Assembly) & FMEA.
  • Develop manufacturing planning, initial tooling requirements and costs, capability requirements, control plans, and assessments, which facilitate the definition and specification of the assembly processes.
  • Create Production Documentation including Manufacturing, Inspection, and Test Instructions and Procedures and submit for approval using document change order procedures.
  • Author, edit, and/or contribute to Project Management documentation, which will include Product Requirement Specifications, System Risk Analysis, and Design and Process FMEA's.

REQUIREMENTS:
MUST HAVE:
  • BS in Engineering plus 8+ years of experience working in an FDA/ISO regulated Medical Device/ Medical Equipment Industry, or equivalent education and years of experience.
  • Experience in-depth Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validation plans.
  • Experience in the selection and qualification of stand alone capital equipment.
  • Ability to work with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixture design and development activities.
PREFERRED:
  • Experience with automated assembly machines, robotics, PLCs, injection molding, plastic joining, potting, biocompatibility, sterilization, automated inspection and/or fixture design preferred.
  • Experience using Minitab or similar statistical evaluation software/tools preferred.
PLUS
  • Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.