NPD Process Development Engineer with Lean Manufacturing experience required to develop new & existing manufacturing processes by medical devices multinational in Galway

Critical Requirements:

  • Level 8 Engineering Degree, or equivalent qualification
  • 3 – 5 years’ experience in a similar role
  • Knowledge of ISO and FDA compliance with an emphasis on validation
  • 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
  • Strong mechanical background
  • Experience in the development of test methods and associated product testing
  • Strong technical background and capabilities
  • 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

Advantageous:

  • Project Management and previous Team Lead responsibilities
  • AutoCAD, Solidworks and Minitab experience 
  • Previous experience of working within a medical device environment
  • Good working knowledge of metals & plastics processing 
  • Knowledge of change management in medical device environment 

Responsibilities:

  • Work as part of the NPD 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 NPD 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 Devices 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

Please contact Emer Smith to discuss in confidence

00353578638188

emer@emtechrecruitment.ie 

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