Job Description

  • Employment Type: Contract
  • Job Location: Galway
  • Date Posted: Posted 7 months ago
  • Salary:DOE

A Medtech Company based in Galway is expanding it’s team and is currently recruiting for a Senior Process Development Engineer. The successful candidate will develop manufacturing processes for products through development of innovative manufacturing solutions both in-house and at suppliers and manufacturing partner sites.


  • Full responsibility for the process development life cycle from ideation through to commercial validation.
  • 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.
  • 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 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.

Qualifications & Experience:

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

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