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Manufacturing Engineer

EmployBridge

This is a Full-time position in Westminster, CO posted September 24, 2021.

Employbridge Search Group has a client in Westminster, CO that is looking for a Manufacturing Engineer to join their team! This is an exciting opportunity with a growing company, competitive salary, and benefits!

Job Duties

  • Completes assigned projects as required for production
  • Support company goals and objectives, policies, and procedures that comply with worldwide regulations
  • Develop and perform validations protocols and reports (IQ, OQ, PPQ) in association with production process, equipment and facility needs
  • Help develop processes and procedures for new product lines while solving production related problems and document solutions for existing product lines
  • Become SME on individual production lines providing technical and performance support while also giving regular updates and metrics report puts to management and clients
  • Develop device master records (DMR) for new Client products and improve efficiencies of existing Client product lines
  • Provide DFM/DFA support during development of NPI products
  • Support Prospect ERP system which includes receiving inspection methods, support equipment, labeling, warehousing, and personnel training
  • Review nonconforming product, assess condition and viable rework, and prepare rework instructions
  • Correct quality issues which may include meeting with management to develop quality or process improvement plans for the long term
  • Support management of new and existing equipment files including facilitating calibrations, preventative maintenance, equipment improvements and procurement
  • Proactively report project activities, issues, and schedule to management
  • Collect, analyze, and interpret manufacturing data to make sound decisions which impact production, personnel, and processes
  • Ensure production equipment is evaluated for safe operation and proper safety measures are in place as needed
  • Support incoming inspection, finish good inspections, and final produce release for distribution
  • Provide guidance and training to production operators as needed in support of NPI and ongoing production while listening to their feedback regarding process improvements
  • Other dues as assigned

Qualifications

  • Bachelor’s Degree in Engineering (BSME, BSEE, BSBE, etc.) is required
  • Minimum 5+ years engineering experience in medical device manufacturing or contract manufacturing
  • Significant experience with FDA GMP, CE, UL and ISP 13485 preferred
  • Working familiarity with SPC and process control methodologies
  • Experience with production automation is preferred
  • Lean manufacturing experience is highly preferred
  • Experience with transferring products from design through validation into manufacturing
  • Experience with both low complexity/high volume and high complexity/low volume production both in and out of ISO Class 7/8 Classrooms
  • Able to create components, assemblies, and drawings as well as understanding GD&T
  • Proven professional qualities, including strong initiative, integrity and desire/ability to work and grow in a dynamic team environment
  • Proven history of being able to consistently promote a positive, professional atmosphere and support activities that enhance the welfare and morale of employees even during periods of shifting priorities
  • Proven problem solver with excellent track record of providing effective solutions based on data analysis and building strong relationships with key stakeholders
  • Ability to perform excellent work with moderate to medium supervision/direction
  • Highly experienced with Microsoft Office Suite to create documentation, spreadsheets, and databases to support manufacturing operations