Project Engineer

Location

Galway

Department Name

Engineering

Functional area

Engineering

Reports To

Principal Engineer

Job Summary

Responsible for scoping, planning, monitoring and managing projects from concept to execution in a high variety award winning Medical Device company in such functional areas as product & process design, assembly, test and packaging.

Duties / Responsibilities

  • Scoping out projects with due regard to objectives, need, cost, risk, lead time and resources
  • Determining key inputs & requirement for project appraisals and approval
  • Analyzing project Capex approval and return on investment attractiveness
  • Determining project specifications
  • Confirming key project performances to manage risk
  • Determining project responsibilities and phases
  • Determining detailed schedules, cost and resource needs
  • Determining and managing critical path activities
  • Planning, monitoring and executing on projects
  • Providing project status reports to various stakeholders at different levels
  • Being prepared to present & represent project documentation in an audit by customers, revenue or regulatory authority.
  • Maintaining compliance with all manufacturing and quality related documentation
  • Performing other assigned tasks as directed by Supervisor or  Head of Function

Specific Requirements

  • Outstanding people management and interpersonal skills
  • Ability to use influencing and persuasive skills to advance project objectives
  • 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 supplier, customer, marketing, and regulatory teams
  • Methodical and analytical approach with good problem solving tool skillsets
  • 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.

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.
  • Very familiar with M/s office key packages
  • Highly motivated self-starter

Education / Experience

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

 

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.