Sustaining Engineer

Location

Galway

Department Name

Manufacturing

Functional area

Engineering

Reports To

Operations Manager

Job Summary

Responsible for sustaining of existing Class II products in a high variety Medical Device assembly, test and packaging environment. Providing production engineering support to components and sub-assemblies in this high growth company.

Duties / Responsibilities

  • Continually assessing and reviewing day to day production issues
  • Monitoring and analyzing quality and production yields
  • Driving and delivering on set (KPI) targets
  • Monitoring of capacity, identifying bottlenecks and line balancing issues
  • Implementation of lean and operational excellence principles (6σ, 5S, TPM)
  • Troubleshooting line issues identifying causes and present resolutions for same
  • Identify areas for improvement and propose solutions for implementation and approval
  • Carry out root cause analysis identifying corrective measures and documenting of same
  • Monitor line performance, seeking and qualifying improvements as necessary
  • Implement product and process engineering change notifications
  • Liaise with stakeholders (colleagues & suppliers) to derive the necessary outcomes
  • Be prepared to represent such documentation in an audit by customers, revenue or regulatory authority.
  • Maintain compliance with all manufacturing and quality related documentation
  • Perform other assigned tasks as directed by Supervisor or  Head of Function

Specific Requirements

  • Green or black belt certification an advantage
  • Knowledge of layouts, labelling, and packaging an advantage
  • Knowledge of Design Verification and Process Validations, particularly as it pertains to equipment and manufacturing processes
  • Excellent understanding of ISO 13485 and FDA Design and Development Processes.
  • Good organisation, planning and communication skills
  • Ability to work as part of a multi-disciplinary team.
  • Experienced in dealing with marketing, and regulatory teams
  • Methodical and analytical approach with good problem solving tool skillsets
  • Leads complex problem solving and cost/capacity improvement projects with cross functional teams
  • Ability to present ideas and concepts clearly and effectively
  • Familiar and comfortable with standard medical device documentation
  • Ability to grasp and statistically analyze data to achieve desired outcomes.
  • Highly motivated self-starter

Education / Experience

  • 4 years’ equivalent experience in a Medical Process Development or Manufacturing Environment
  • Minimum of a primary degree in an Engineering or Technological Discipline

 

Environmental Conditions 

  • Typical office environment with work also performed in Development labs and Manufacturing areas in addition to customer/supplier locations
  • Some travel may be required with role.

Closing Date for Application

Closing Date 7th April 2017

Aerogen is the world’s leading medical device company specialising in the design, manufacture and commercialisation of aerosol drug delivery systems. 

Founded in Galway, Ireland in 1997, we have grown to become the global leader in high performance aerosol drug delivery, partnering our technology with the leading mechanical ventilation companies. 

Aerogen technology is used by millions of patients and caregivers in over 75 countries worldwide.

To find out more go to www.aerogen.com 

Some of the benefits our employees enjoy at Aerogen: 

  • VHI including Dental
  • Pension
  • Bonus
  • DIS
  • PHI
  • On-site Free Parking
  • Paid Holidays
  • Sports & Social Club
  • Flexi Start Time