A Senior R&D Engineer is required by CareerWise Recruitment for our client based in NorthWest Dublin. The role fulfils a key component of the Instrument Development and Validation team. The incumbent will be required to interface with all other functions with the project as required, with the Assay Development team, Quality Assurance and Regulatory teams. The incumbent will be a key contributor to technology development for the product Platform encompassing instrument, microarray and manufacturing system. Develop, design and deliver engineering and scientific technical solutions to enable the continued development and commercialisation of products. Please contact Tom Devaney for more information.
Role of this position
Develop Design Input Requirements for Hardware (specifically imaging system design) requirements
- Develop the instrument design input requirements for instrument hardware, firmware software associated with measurement principles of instrument based on risk analysis approach
- Review design output requirements including performance of technical reviews to align on design with development partners.
- Characterise performance of design outputs with dedicated development studies and define conclusions / successfulness of design.
- Support product lifecycle management of hardware including risk analysis, design input development, design output development, verification and validation and post launch activities.
- Software development expertise to compliment data output
Develop design output requirements for system measurement systems (optical) o Responsibility for development of image analysis / algorithm activities for analysing processed hybridised microarrays.
- Support the characterisation of the assay states / edge cases based on risk analysis approach and develop algorithm accordingly.
- Develop infrastructure to support the system performance characterisation (including manufacturing of individual components / QC release functions/ development activities / verification / validation)
- Support development of bespoke reports to support system characterisation efforts.
- Support Verification / validation for instrument formal lifecycle activities.
- Support and / or develop infrastructure to analysis data for clinical trial and post launch activities pre / post commercialisation.
- Engineering or Science degree or related discipline
- Minimum 5-10 years' experience in regulated environment. Also experience within a R&D development environment with knowledge of Design control processes.
- Expert in data science infrastructure development expertise in common data visualisation tools and software development tools such as R, SQL, Python, Java, MATLAB, C++, .NET, visual basic.
- Experience working within a regulated environment with specific knowledge of ISO 13485, FDA 820 / current Good Manufacturing Practice
- First-hand experience of audits by regulatory authorities
- Expertise/ knowledge in Optical system design principles.
- Expert in Image processing techniques utilising but not restricted to Open-source frameworks and libraries.
- Experience in optical system design a distinct advantage
- Full and comprehensive Spec available on request
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)