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Job Opportunity - Senior Manufacturing Process Engineer

Posted on Dec 31, 2017 by Administrator

Job Opportunity - Senior Manufacturing Process Engineer

Job Description

As a Senior Manufacturing Process Engineer, each day will offer new challenges as you tackle a variety of responsibilities, including Oversight of 4 existing engineers and 15 Contract employees. Managing all aspects of different projects and overseeing the machine operations, resolving issues on machines.  Experience with FDA documentation, validations, VFDA, QSR.


Job Duties:

  • Take ownership of project success for new and existing families of production.
  • Coordinate cross-functional teams to execute and document the manufacturing launch of new/legacy products.
  • Determine manufacturing processes required to accurately and efficiently make spinal implants, from raw material to final cleaning and shipment.
  • Interface with Quality Engineering to determine critical manufacturing process and control characteristics.
  • Develop and complete manufacturing documentation (pFMEA, control plan, process flow, work instructions, and inspection plans).
  • Perform research, design, and development of manufacturing processes including production flow, assembly methods, and production equipment.
  • Execute the Engineering Change Process for process updates and improvements.
  • Perform product/process analysis and troubleshooting for cost reduction, quality improvement, and improved efficiency.
  • Design, develop, test, source, and cost-justify various tools, machinery, and equipment for recommended manufacturing methods.
  • Coordinate and manage the estimating/quoting process.
  • Lead design for manufacturability analysis with CNC Programmers and Quality Engineers, and provide input to Development (Design) Engineers.
  • Support process validation by working with validation engineers to clarify methods, inputs, and outputs of processes or equipment.
  • Implement, maintain, analyze and react to various production data logs.
  • Participate in NCMR Process in containment, root cause analysis, and implementation of permanent corrective actions.

Job Requirements:

  • 5-10 years experience
  • Must have managed projects – to include financials and timelines
  • Proficient with Microsoft office

Preferred Qualifications

  • Proven ability and fluency in Print Reading and GD&T, Statistical Process Control, Lean Manufacturing, Six Sigma
  • Experience in 21 CFR 820 and/or ISO 13485 regulated environment
  • Experience in a CNC manufacturing environment is preferred.


Educational Requirements:

  • Bachelor’s degree (BS); in a technical engineering discipline.


For confidential consideration please send details to:


Jill Martinellii

Director of Technical Recruitment

TriStaff Group | San Diego, CA 92122


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