Process Development Engineer

Location: Galway, County Galway, Ireland
Salary: €50000 - €55000 per annum +
Sectors: Operations
Job Type: Permanent
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Job Purpose

Develop, characterise and validate manufacturing processes including injection moulding, robotics, test instrumentation, vision systems and automated assembly equipment for the production of Class II respiratory drug delivery products.


  • Leadership and support of suppliers on manufacturing capacity expansion including full qualification of increased injection moulding cavitation and capacity.
  • Leadership and support of suppliers on a range of assembly and test processes including manual, semi-automated and fully automated equipment as well as standard and bespoke inspection systems.
  • Lead process implementation and validation projects through companies validation and verification life cycle as part of a cross functional team.
  • Responsible for design, research and development and project management of new processes through the stage gated development process to achieve the required capacity, quality, and cost requirements.
  • 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 life-cycle.
  • Perform other assigned tasks as directed by supervisor or head of function


  • 5 years' equivalent experience in a medical process development or manufacturing environment
  • Minimum of a primary degree in an engineering or technological discipline

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.
  • Injection moulding process characterisation and validation experience.
  • Excellent understanding of ISO 13485 and FDA design and development processes as well as GAMP methodology.
  • 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 analyse data to achieve desired outcomes.
  • Highly motivated self-starter

Environmental Conditions:

  • Office environment with work also performed in development labs and manufacturing areas in addition to customer/supplier facilities.
  • Some travel may be required with role.

To find out more about Real please visit

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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