NPI Process Development Engineer required to develop existing & new processes & to lead new product introduction cycle – by medical devices multinational in Galway for 9-mth contract

Responsibilities:

  • Work as part of the NPI team to drive product and process improvements
  • Manage new designs through product lifecycle into manufacturing
  • Work closely with Subject Matter Experts in the business to ensure all new product fit within existing manufacturing capability
  • Work closely with Lean and Operations teams to ensure that any new processes developed meet world-class manufacturing standards
  • Display customer focus always and be accountable for quality and timeliness of own work
  • Manage a variable workload across different projects to meet NPI requirements
  • Design and introduce manufacturing processes for new products to meet the demands of productivity and quality
  • Ensure that complete and effective validations are carried out on all processes before transferring to manufacture including IQ, OQ, PQ & PPQ
  • Identify and put in place permanent and effective technical/system solutions to problems
  • Maintain high quality/compliance standards in line with Medical Device manufacturing requirements
  • Applying Lean principles to identify and develop improvements that increase key process metrics of yield, throughput and productivity
  • Investigate new process technologies and evaluate potential competitive advantage and the cost-benefit of introduction
  • Manage external relationships with technology providers/suppliers
  • Ensure that all Health, Safety and Environmental requirements are fulfilled

Requirements:

  • Level 8 Engineering Degree, or equivalent qualification
  • 2+ years’ experience in an NPI leadership role
  • Strong technical background and capabilities
  • Knowledge of Six-Sigma methodology, problem-solving tools and Lean Manufacturing principles
  • Knowledge of equipment, process and product validation processes, ability with statistical data analysis
  • Experience in the development of test methods and associated product testing
  • Motivated to work on own initiative and the ability to make and implement decisions
  • Excellent communication, planning and organizational skills
  • A demonstrated ability to solve problems with innovative and cost-effective solutions
  • Computer literate and familiar with all Office software packages
  • Proven track record of excellent timekeeping & attendance is essential
  • AutoCAD, Solid works and Minitab experience preferable
  • Previous experience of working within a Medical device environment would be a distinct advantage
  • Knowledge of ISO and FDA compliance with an emphasis on validation
  • Strong mechanical background with a good working knowledge of metals & plastics processing a distinct advantage
  • Knowledge of change management in Medical Device environment is advantageous

Please contact Emer Smith in confidence

+353578638188

emer@emtechrecruitment.ie

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