Process Development Engineer

Location

Galway - Ireland

Department Name

Process Development

Functional area

Engineering

Reports To

Principal Engineer

Job Summary

Develop manufacturing processes for Class II respiratory product. Knowledge of plastics, metals, adhesives & process validation. Statistics a bonus. Liaise with in-house & outsourced manufacturing. 5 years equivalent experience. Exciting opportunity in a rapidly growing, multi award-winning company

Duties / Responsibilities

  • Full responsibility for the process development life cycle from ideation through to commercial validation.
  • Responsible for design, research and development of new processes through the stage gated development process to achieve the required capacity, quality, and cost requirements.
  • Conduct material selection taking into account the performance and biocompatibility requirements.
  • Design and develop methods for verification and validation testing of product requirements with due regard to regulatory compliance and in accordance with Aerogen’s quality systems.
  • Participate in supplier selection for device manufacture, tooling and components.
  • Maintain concise and accurate records of the iterative design process, trial and error and experimental steps to support the design history file and for R&D grant and tax credit submissions.
  • Prepare technical documentation in clear and concise terms in accordance with good engineering practice. Be prepared to represent such documentation in an audit by customers, revenue or regulatory authority.
  • Liaise closely with and communicate effectively to the R&D, Manufacturing, Operations, Quality, Sales and Marketing functions through the product development lifecycle.
  • Perform other assigned tasks as directed by Supervisor or  Head of Function

Specific Requirements

  • Technical Leadership and/or Project Management Experience
  • 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.
  • Excellent planning, project management and coordination skills
  • Ability to work as part of a multi-disciplinary team.
  • Methodical and analytical approach.
  • Ability to present ideas and concepts clearly and effectively to all levels of the company.
  • Ability to manage risk in striving to meet objectives
  • Ability to grasp and statistically analyze data to achieve desired outcomes.
  • Highly motivated self-starter

Education / Experience

  • 5 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