Collins McNicholas

 

Senior Data Management Engineer

 

Reports to: VP

Team: Project & Development Team

 

Team Overview

  • Responsible for the development of the Automated Immunohematology instrument and all associated peripherals, for the purpose of enabling the assay for processing the MicroArrays.
  • Responsible for defining requirements from user needs, understanding internal needs of the assay development team and producing all associated requirements documents, realizing the documented requirements through development.
  • All development activities are completed in compliance with proceduralised Design Control.
  • The strategy is to outsource the design and manufacture of the Instrument to a Third Party manufacturer with core skill-set in this area. The team must ensure design outputs meet input needs – this requires the team to cover a broad range of technical areas including Design control for Hardware, Software and usability; Document control for DMR/DHR inclusion to ensure Regulatory compliance.

 

Job Purpose / Objective

  • The Senior Data Management Engineer will be primarily responsible for working with a third-party development company to develop a middleware interface solution to enable the instrument to integrate into a laboratory environment and transmit data generated on it to the laboratory IT infrastructure (LIMS/LIS).
  • The role will also be responsible for identifying other or bespoke solutions for data transfer as required.
  • Other secondary responsibilities will focus on the methodologies employed on the Immunohematology instrument to accumulate and interpret data for purpose of result generation.

 

Main Responsibilities

  • Guiding the third-party developer to ensure the middleware solution meets all technical, regulatory and business requirements.
  • The definition and development of inputs (via URS) / requirements, supporting development through providing expert technical guidance and problem solving to enable an acceptable output.
  • Defining verification and validation testing requirements of the product when interfaced.
  • Establish and maintain a high level of functional and technical product expertise to benefit development activities and business progress.
  • Leverage experience in development of complex, sophisticated solutions within a highly regulated environment.
  • First point of contact for all related enquiries and work collaboratively with the wider-development/testing/regulatory team to address any issues that may arise, driving potential solutions across the development cycle.
  • Work with stakeholders to identify, define and document constraints and assumptions within the development cycle and implement robust solutions.
  • Technical Lead and support Hazard Analysis and Risk Management activities, including FMEA’s, to ensure robust and reliable designs.
  • Lead and support internal Technical Reviews & Design Reviews.
  • Create and execute test documentation to a high and exacting standard, ensuring all documentation generated is QMS compliant. Ensure all activities comply to the QMS requirements.
  • Act as an expert in the application of Product Lifecycle Management methodologies.
  • Hands-on software development responsibility throughout all phases of Product Lifecycle.
  • Perform any duties as reasonably requested from the company from time to time.
  • Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements.

 

Essential Qualification / Skills

  • BSc / equivalent in Software Engineering or Computer Science
  • Strong working knowledge of Software Design, Requirements Definition and Validation / testing activities
  • Life Sciences or bioengineering experience within a multi-disciplinary environment.
  • Experience bringing regulated products from development through to commercial readiness.
  • Experience of working with recognised development processes with experience of all stages of the Software Development Lifecycle.
  • Extensive experience in a GMP/GLP environment.
  • Exposure to Internal and external audit.
  • Detailed experience of software / module development & testing in IVD / Medical Device industry
  • Demonstrable track record of the application / usage of middleware within a medical laboratory (with experience of LIMS/LIS/BECS)
  • Detailed understanding of TCP/IP communication protocol; HL7 & ASTM standards.
  • Experience using Risk management tools and techniques to develop solutions.
  • Understanding of medical device regulations including ISO, FDA, GMP and design controls.
  • Experience in documenting medical device requirements (design inputs) with accuracy and testing outputs to ensure inputs are achieved.
  • Flexibility to travel up to 30% of time. Some travel may be at short notice.

 

 

Desirable Qualifications / Experience

  • Master’s Degree or other advanced level qualification
  • Experience in IH products
  • Working in a PM driven environment to ensure compliance to Design Control requirements
  • Assay development knowledge to enable an understanding of an Assay integration process
  • User of Middleware / LIMS systems within a medical laboratory
  • Ability to effectively present complex technical information to non-technical audiences.
  • People management / supervisory experience.
  • French or German are a distinct advantage

 

 Apply Now

  • For a confidential discussion and more information on the role, please contact Blaithin on 01 66 200 88 or email blaithin.oshea@collinsmcnicholas.ie
  • For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
  • Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!

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