Senior R&D Engineer

CAREERWISE RECRUITMENT

DUBLIN

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. THE ROLE: 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. REQUIREMENTS: * 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: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1674 days ago