New Products/Process Introduction Engineer

Location

Galway

Department Name

Manufacturing

Functional area

Engineering

Reports To

Operations Manager.

Job Summary

Working as part of the Operations group you will be responsible for the handover of Medical Device Class II electromechanical respiratory products/processes from the R&D and Process Development groups to manufacture and subsequent release to sales in a high growth innovative and multiple award winning company.

Duties / Responsibilities

  • Manufacturing representative on the cross functional product design team
  • Designing for manufacture, test, packaging and labelling
  • Participate in supplier selection for device manufacture, tooling and components.
  • Carrying out process risk assessments (pFMECA)
  • Validating of production equipment (IQ, OQ, PQ, PPQ) including the completion of the validation reports
  • Validating test equipment (TMV’s, Gauge R&R)
  • Validating of packaging to current standards
  • Setting up all relevant documentation; bills of materials, process flow charts, work instructions e.t.c.
  • Mentoring and developing of operators and technicians to ensure smooth running of manufacturing process
  • Carry out root cause analysis as appropriate, identifying corrective measures and documenting of same
  • Implement product and process engineering change notifications
  • Liaising 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

  • Outstanding documentation skills with great attention to detail
  • 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
  • Strong team player with excellent ability to work as part of a multi-disciplinary team.
  • Experienced in dealing with  Quality, 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
  • 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

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.