Senior Data Management Engineer
Reports to: VP
Team: Project & Development Team
- 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.
- 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
- For a confidential discussion and more information on the role, please contact Blaithin on 01 66 200 88 or email firstname.lastname@example.org
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