Senior Operations Engineer

Location

Galway - Ireland

Department Name

Operations

Functional area

Operations

Reports To

Operations Manager

Job Summary

  • Dynamic, analytic Senior Engineer with leadership qualities required to review existing operations and develop infrastructure and processes for a growing manufacturing business in a fast-moving, dynamic medical device organization.
  • This role will provide technical and organizational leadership in the functioning of Aerogen’s own manufacturing and contracted activities.
  • The person will require strong project management skills with good attention to detail and be skilled is using both problem solving and data analysis tools

Duties / Responsibilities

  • Review of existing processes to achieve greater capacity, lower costs of manufacture and more robust manufacturing processes
  • Provide technical and organizational leadership to engineers and technicians for production support, process troubleshooting and process improvement.
  • Spearhead activities to introduce new products and new manufacturing processes into the manufacturing environment.
  • Lead the qualification of new equipment and processes including the completion of process validations (IQ, OQ, PQ & PPQ).
  • Determine and implement infrastructure requirements for new Aerogen processes and equipment.
  • Mentor and develop manufacturing engineers and technicians on critical manufacturing processes and equipment, maintaining knowledge and expertise.
  • Lead team to develop and execute initiatives to improve production floor layout with a focus on lean manufacturing principles and techniques.
  • Lead problem solving activities using modern six sigma tools and techniques to quickly get to root causes.
  • Participate in supplier selection for services and component supply as well as device manufacture
  • Driven yield optimization through ongoing improvement initiatives.
  • Ensure work completed is compliant with quality and regulatory standards.
  • Communicate regular and accurate on project deliverables to Aerogen Management identifying where divergences occur with options for their resolution.
  • Maintain project and technical files in accordance with Aerogen’s Medical Quality Standards.
  • Assist in risk analysis and business continuity identification and mitigation.
  • Responsibility for specification changes where required.
  • Perform other tasks as identified by the Head of Function.

Specific Requirements

  • Highly motivated self-starter
  • Ability to work as part of a multi-disciplinary team with good interpersonal skills.
  • Strong understanding of ERP systems is an advantage.
  • Proficiency in use of desktop software applications such as MS office.
  • Methodical and analytical approach to problem solving and be capable of working on own initiative.
  • Excellent planning skills, with proven project management skills.
  • Excellent verbal and written communication skills.
  • Excellent understanding of quality systems in a regulated environment
  • Ability to lead a team and develop the collective team’s knowledge.
  • Excellence in customer fulfillment
  • Objective and target driven to achieve desired results

Education / Experience

  • National Degree or Equivalent in engineering with 10 or more years manufacturing, process introduction and new product transfer experience in medical device, commercial device, or related areas.

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