Jobs
>
Dublin

    Software Design Assurance Engineer - Dublin, Ireland - Pharmiweb

    Pharmiweb
    Pharmiweb Dublin, Ireland

    1 week ago

    Default job background
    Description

    On behalf of our client, a growing medical technology company based in Dublin, we are currently recruiting for a Software Design Assurance Engineer. The Software Design Assurance Engineer will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software.

    Responsibilities and Essential Functions:

    • Provide Software Quality leadership for new product introductions and sustaining product development teams.
    • Work closely with Software development team on process optimization for efficient iterative generation and maintenance of regulatory deliverables.
    • Support the creation and review of all medical device software documentation including Software Development Plans, Design Specifications, Software Safety Classification, Software Design Verification
    • Testing plans, protocols and reports, software issue tracking and resolution, cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.
    • Develop Test plans, and test cases based upon the product and component level requirements. Understanding of all aspects of the QMS related to Design Controls.
    • Ensure that product development projects and changes to existing products are conducted in compliance with the applicable regulations and standards, and internal company procedures.
    • Provide detailed assessments of impacts for design changes on commercialized products.
    • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
    • Lead the creation and review of risk management files to include the risk management plan, product hazard analysis, FMEA's, Risk Management Matrix, and Benefit Risk Determination.
    • Ensure Risk Management effectively integrates feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HRAs, etc. Familiarity with ISO 14971, Risk management for medical devices and IEC 62304 Medical Device Software.
    • Understand and support all aspects of the QMS related to Design Controls. Develop and report status of Quality and Reliability metrics during phase reviews.

    Education, Qualifications and Experience:

    • You have a bachelor's degree or higher in a related field. 3+ years in regulated work environment including at least 2 years in Medical Devices.
    • Technical expert with strong communication skills.
    • Experience with verification and validation (V&V) required.
    • Expert knowledge of IEC Software Development Life Cycle).
    • Good working knowledge of ISO13485 and ISO14971. IEC 62366 knowledge preferred (Usability).
    • Understanding of MDR and CFR requirements.
    • Prior experience with Jira/Structure/templated export or equivalent software tooling.

    Additional Attributes:

    • Comfortable working within and influencing cross-functional teams.
    • Excellent analytical and problem-solving skills.
    • Motivated self-starter with the ability to work independently and collaboratively.
    • Able to follow established policies and procedures, create new processes and procedures, and comply with regulatory requirements.
    • Able to identify problems and propose/implement solutions.

    For full details contact Linda at or email your CV to Thornshaw Scientific is a division of the CPL Group

  • Ryanair

    Quality Assurance Engineer

    1 week ago

    Ryanair Dublin, Ireland

    Ryanair are currently recruiting for a Quality Assurance Engineer to join Europe's Largest Airline Group · This is a very exciting time to join Ryanair as we look to expand our operation to 800 aircraft and 300 million guests within the next 10 years. · The Quality Assurance Engi ...

  • Wallace Myers International

    Design Assurance Engineer

    5 days ago

    Wallace Myers International Ireland Full time

    Job Specification - Design Assurance Engineer · Position Overview · The Design Assurance Engineer will be instrumental in ensuring the quality, safety, and regulatory compliance of medical devices throughout the product development life-cycle. This role offers an exciting oppor ...

  • Klir, Inc.

    Software Quality Assurance Engineer

    4 days ago

    Klir, Inc. Dublin, Ireland

    Water, a resource of unparalleled importance, is often deemed the lifeblood of our planet. However, the water industry has long been criticized for its reluctance to innovate and embrace new technologies that could liberate skilled professionals from the tedious, time-consuming a ...

  • Cpl

    Software Design Assurance Engineer

    4 days ago

    Cpl Dublin, Ireland Full time

    On behalf of our client, a growing medical technology company based in Dublin, we are currently recruiting for a Software Design Assurance Engineer. The Software Design Assurance Engineer will work closely with colleagues to support the development, qualification, and commerciali ...

  • TiVo Corporation

    Sr Software Engineer, Audio Quality Assurance

    4 days ago

    TiVo Corporation Ireland

    Engineer - Audio Quality Assurance (with Python) · Xperi invents, develops and delivers technologies that create extraordinary experiences at home and on the go for millions of people around the world. Powering billions of consumer electronics, connected cars and digital content ...

  • Universitätsklinikum Freiburg

    Medizininformatiker/in, Data Engineer,Informatiker/in

    1 day ago

    Universitätsklinikum Freiburg Dublin, Ireland

    Krankenhausinformationssysteme, Informatik,Softwareentwicklung, Data Engineering, ETL, Scripting, Java,Programmiersprachen, IT, Apache Kafka, HL7, Datenbanken, DataWarehousing, Business Intelligence, ObjektorientierteProgrammierung German · Language German (Germany) English (U ...

  • Prometric Ireland Limited

    Application Security Engineer

    1 week ago

    Prometric Ireland Limited Ireland

    Job Title: Application Security Engineer · Reports To: Head of Information Security · Department: Information Security · Location: Remote - Ireland · Hours of Work: 37.5 hours weekly · Job Overview: · As a Prometric Application Security Engineer you will be a member ...

  • ICDS Group

    Design Manager

    5 days ago

    ICDS Group Dublin, Ireland Freelance

    Design Manager (main contractor) Dublin South €70-80k + package Required for Tier-1 award winning contractor undertaking a large commercial and residential projects across Dublin to €150m. The successful candidate will have an Architectural/Engineering background along with 5+yea ...

  • Malachy Walsh And Partners

    Resident Civil Engineer

    5 hours ago

    Malachy Walsh And Partners Dublin, Ireland

    MWP requires a Resident Civil Engineer with Marine experience.The position would suit a motivated, practical, and adaptable individual who has the ambition to work in a progressive and innovative Engineering and Environmental Consultancy.The ideal candidate will be based on site ...

  • Reperio Human Capital (Ireland) Ltd

    Software Test Engineer

    5 days ago

    Reperio Human Capital (Ireland) Ltd Dublin, Ireland

    Software Test Engineer - Dublin, €55,000 - €65,000, Hybrid I have partnered with a Software Development Company based in Dublin who are looking for a Software Test Engineer to join their team. Role & Responsibilities: Design, create and implement automated test plans. Monitor and ...

  • Asset Recruitment

    Active Travel Design Engineer

    5 hours ago

    Asset Recruitment Dublin, Ireland

    Our client, a global EPCM company, is seeking a dedicated individual experienced in Active Travel Design projects. · Role · The position involves working within our clients Active Travel Design team, contributing to a variety of active travel projects for their key clients. We ...

  • Cpl Healthcare

    CSV Engineer

    5 hours ago

    Cpl Healthcare Dublin, Ireland

    CSV Engineer (Computer System Validation Engineer) · My client based in Dublin 15 is looking for a CSV Engineer (Computer System Validation Engineer) to join their team and someone who is responsible for validating and maintaining computerized systems to meet regulatory requireme ...

  • Sabeo Contracting Services Ltd

    Software Engineer

    5 hours ago

    Sabeo Contracting Services Ltd Dublin, Ireland

    Software Engineer (Test Automation) · Permanent · Hybrid – Dublin city centre · Our high-profile client is actively seeking a Software Engineer (Test Automation) who is passionate about Software Quality, has an Agile Tester mindset, and has a track record for building effectiv ...

  • Asset Recruitment

    BIM Coordinator

    5 hours ago

    Asset Recruitment Dublin, Ireland

    REF:01190 · BIM Coordinator · Asset Recruitment proudly presents an opportunity for a BIM Coordinator to join our client, a growing specialist Mechanical and Process Engineering contractor · Responsibilities: · Develop 3D construction models using base information such as PID' ...

  • AtkinsRéalis

    Design Engineer

    5 hours ago

    AtkinsRéalis Dublin, Ireland

    AtkinsRéalis Ireland is a member of SNC-Lavalin, one of the world's leading providers of engineering professional consulting and support services with offices across Ireland. · We have an opportunity for a Design Engineer with 3+ years' experience in the water/wastewater secto ...

  • Glenveagh Homes Limited

    Site Engineer

    5 hours ago

    Glenveagh Homes Limited Ireland

    Working for Glenveagh Properties is exciting, challenging and incredibly rewarding. We're using advanced technology and cutting-edge construction methods to create quality homes in communities across Ireland. · The Infrastructure Engineer is responsible for supporting the coordi ...

  • Headcount Group

    CSV Engineer

    5 hours ago

    Headcount Group Dublin, Ireland

    Headcount Solutions is seeking a CSV Engineer to join the team at a multinational client's biotech facility in Dublin. The CSV Engineer will be responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices. Responsibi ...

  • NRL

    Senior Electrical

    5 hours ago

    NRL Dublin, Ireland

    About the job: · As one of our Senior Electrical Engineers you will lead projects in EMEA, for companies who lead in technology driven solutions. It will be second nature to you, to manage project delivery from conception all the way through to completion / client handover. Conf ...

  • Access Talent Group

    Site Engineer

    5 hours ago

    Access Talent Group Leinster, Ireland

    Competitive Pension & Holiday Allowance including a Company Vehicle · Our client is one of the leading main contractors in the East of Ireland, with pipeline of working growing an a positive rate. The current opportunity is for aspiring / proven Site Engineers to join an already ...

  • Archer Recruitment

    Network and Security Engineer

    5 days ago

    Archer Recruitment Dublin, Ireland

    Network and Security Engineer - Design focus. A new role that is the result of organic growth. Influence both Networking And Security Architecture. Highly competitive salary (105k) with additional benefits. Join this Irish organization as a Network and Security Engineer. This is ...