Senior Process Development EngineerJob Summary:
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 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
•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.
For further information on this role in Galway please contact Anna McGowan on 086-4667369 / firstname.lastname@example.org
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