Senior Process Development Engineer
Galway Municipal District - This Area Only
Develop manufacturing processes for Class II respiratory drug delivery products through development of innovative manufacturing solutions both in-house and at suppliers and manufacturing partner sites.
The Senior Process Development Engineer has the authority, by prior arrangement, to act on behalf of the Principal Engineer.
•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 Aerogens 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
•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
•Ability to grasp and statistically analyze data to achieve desired outcomes.
•Highly motivated self-starter
•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.
Posted 7 days ago