Job Title: Manufacturing Engineer II x3 (Projects) Location: Clonmel, IrelandOverview Join a world-leading organisation at the forefront of innovation in medical device manufacturing. As a Manufacturing Engineer II, you&rsquo;ll drive efficiency and quality within production, tackle complex engineering challenges, and play a pivotal role in integrating cutting-edge processes and products. This is your opportunity to advance your career in a thriving, supportive, and globally recognised company based in the vibrant community of Clonmel, offering an outstanding quality of life amidst Ireland&rsquo;s scenic beauty and rich heritage.Key Responsibilities<ul><li>Process Optimisation: Streamline production operations by monitoring equipment, tools, and processes, addressing performance issues to ensure optimal output, product quality, and cost efficiency.</li><li>Product and Process Development: Lead technical initiatives to enhance current processes and drive innovation in next-generation programmes, aligning with strategic goals.</li><li>Problem Solving and Analysis: Apply advanced engineering principles to solve complex challenges, develop novel solutions, and drive breakthroughs in manufacturing technology.</li><li>Reporting and Communication: Prepare detailed reports, share insights through presentations, and communicate findings effectively with internal stakeholders.</li><li>Leadership and Collaboration: Mentor colleagues by sharing technical expertise, guiding project teams, and setting clear goals and objectives for collaborative success.</li><li>Quality Commitment: Demonstrate unwavering dedication to product quality and patient safety by adhering to quality system policies and regulatory standards.</li><li>The predominant function for these Engineers will be executing validations on duplicate sets of equipment. </li></ul> What We&rsquo;re Looking For<ul><li>Experience and Knowledge:<ul><li>Strong foundation in engineering principles, concepts, and practices.</li><li>Experience in manufacturing or process engineering roles, preferably within the medical device or regulated industry.</li><li>Working knowledge of industry and business practices.</li></ul></li><li>Skills and Abilities:<ul><li>Problem-solving mindset with the ability to address complex issues and implement effective solutions.</li><li>Excellent communication skills to present ideas and collaborate across teams.</li><li>Capacity to manage tasks independently while contributing to team objectives.</li><li>Equipment Validation Experience.</li></ul></li></ul>Why Choose This Role in Clonmel? Clonmel offers the perfect blend of professional growth and personal wellbeing, with a supportive community, a vibrant local culture, and access to some of Ireland&rsquo;s most stunning landscapes.Ready to Apply? Take the next step in your career by joining a company committed to excellence, innovation, and making a difference in people&rsquo;s lives. Apply today and become part of our success story in Clonmel, Ireland! For further information on this role, please contact Diarmuid Lannon on +353 861287246 or email&nbsp;<a href="mailto:consulting@hero.ie">consulting@hero.ie</a>&nbsp;Check out all our open jobs on our HERO Recruitment website &ndash; https://www.hero.ie/Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Manufacturing Engineer II

Job Title: Design Assurance EngineerLocation: Galway, Ireland Department: Quality / Design Assurance Reporting To: Design Assurance Manager Type: Full-time, PermanentRole OverviewA highly motivated and experienced Design Assurance Engineer is sought to support the lifecycle of commercially released medical device products. This key role involves managing design changes, ensuring continued compliance with global standards, and supporting post-market activities such as complaint investigations.Key Responsibilities<ul><li>Provide design assurance input on sustaining engineering projects across the full product lifecycle.</li><li>Lead and execute product/material design changes in compliance with global regulatory and quality system requirements.</li><li>Assess changes for design, usability, sterilisation, biocompatibility, and clinical impact.</li><li>Support process changes in collaboration with R&amp;D and Manufacturing Engineering teams.</li><li>Maintain and update risk management files per ISO 14971 and FDA guidelines.</li><li>Generate and execute Design Verification (DV) plans, protocols, and reports.</li><li>Ensure compliance with design control requirements (FDA 21 CFR 820.30, ISO 13485).</li><li>Maintain design history files (DHF) and ensure full traceability of design documentation.</li><li>Support complaint investigations, root cause analysis, and implementation of CAPAs.</li><li>Stay informed on evolving regulatory requirements affecting product design and development.</li><li>Provide technical input into material specs, inspection criteria, drawings, and manufacturing documentation.</li><li>Contribute to regulatory submissions and audit preparation by providing design assurance documentation.</li><li>Collaborate across departments to document and implement product changes.</li><li>Champion continuous improvement initiatives within the design assurance function.</li><li>Mentor junior engineers when required.</li></ul>Qualifications &amp; Experience<ul><li>Bachelor&rsquo;s degree (Level 8 NFQ or equivalent) in Engineering, Science, or a related technical discipline.</li><li>2&ndash;3 years' experience in design assurance, quality engineering, or product development within the medical device sector.</li><li>Strong working knowledge of ISO 13485, ISO 14971, and FDA QSR.</li><li>Hands-on experience with:</li><ul><li>Design controls and verification activities</li><li>Biocompatibility and sterilisation validations</li><li>Risk management processes</li><li>Human factors and usability assessments</li></ul><li>Experience with post-market quality processes, including complaint handling and CAPA.</li><li>Demonstrated ability to work independently on moderately complex projects with general supervision.</li><li>Strong analytical, communication, and documentation skills.</li><li>Ability to manage multiple priorities in a dynamic, fast-paced environment.</li><li>Effective team player with the ability to influence cross-functional collaboration.</li></ul>

Senior Design Assurance Engineer

HVAC Validation Engineer - Waterford&nbsp; Our client is hiring an onsite HVAC Validation Engineer with CTCB-I Professional Certification to join their Technical Quality team, supporting a key pharmaceutical client in Co Waterford. This role ensures compliance with GMP standards across cleanroom and lab environments. Key Responsibilities:<ul><li>HEPA filter testing, airflow visualization, non-viable particulate monitoring.</li><li>Validation of cleanroom environments, LAFs, BSCs, fume cupboards and containment suites.</li><li>Temperature, humidity and pressure control verification.</li><li>Commissioning &amp; test balancing (TAB), system optimization, troubleshooting.</li><li>Audit support and GMP documentation.</li></ul>Qualifications &amp; Experience: <ul><li>CTCB-I Professional Certification (mandatory).</li><li>3+ years in cleanroom validation within pharma/biotech/medical devices.</li><li>Strong knowledge of cGMP, ISO standards and validation protocols.</li><li>Compliance with Health &amp; Safety legislation. </li></ul>For further information on this role please contact Regina Carroll on +353 86 0100 903 or email <a href="mailto:jobs@hero.ie">jobs@hero.ie </a> Check out all our open jobs on our HERO Recruitment website &ndash; https://www.hero.ie/.Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA based on standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location

HVAC Validation Engineer

<aside class="job-preview__other-job-details">Job Title:&nbsp;Wet Process Engineer Location:&nbsp;Wexford, Ireland Department:&nbsp;Engineering / Manufacturing Reports To:&nbsp;Process Engineering Manager Contract Type:&nbsp;Full-Time / PermanentAbout the RoleWe are looking for a highly experienced Wet Process Engineer to join our team on a contract basis as a Subject Matter Expert (SME). You will play a critical role in overseeing and optimising a specialised wet processing line, which includes:<ul><li>Dissolving powders into liquid suspension</li><li>Pasteurising formulations at temperatures up to 85&deg;C</li><li>Injecting oil into the solution</li><li>High-pressure homogenisation</li><li>Final drying through spray drying technology</li></ul>This role is ideally suited for a technically strong process engineer with hands-on experience in thermal processing and complex liquid-to-powder systems in the food or pharma sectors.Key Responsibilities<ul><li>Lead process design, optimisation, and troubleshooting from powder dissolution through spray drying</li><li>Define, monitor, and adjust critical process parameters to ensure product quality and system stability</li><li>Work closely with operations, automation, and quality teams to deliver improvements in throughput, yield, and consistency</li><li>Support process commissioning, validation, and technical documentation</li><li>Implement best practices in hygiene, safety, and regulatory compliance</li><li>Provide subject matter expertise during audits, risk assessments, and cross-functional investigations</li></ul>Qualifications &amp; Experience<ul><li>Degree in Chemical Engineering, Process Engineering, or equivalent</li><li>Minimum of 5 years&rsquo; experience in a wet process environment (ideally food, dairy, or pharmaceutical)</li><li>Expertise in thermal processing, spray drying, and high-pressure pumping systems</li><li>Strong problem-solving and analytical skills, with experience in data analysis and process diagnostics</li><li>Ability to work independently while engaging collaboratively with internal teams</li><li>Must have the right to work in Ireland; this is a contract role and does not offer visa sponsorship</li><li>Pasteurising Experience</li></ul>Contract Details<ul><li>Duration:6-12 Months</li><li>Start Date: Immediate</li><li>Location: Southeast Ireland with potential for hybrid flexibility</li><li>Rate: Competitive day rate, commensurate with experience</li></ul>To Apply: Please send your CV and a short cover note outlining your availability and relevant experience to consulting@hero.ie</aside>

Wet Process Engineer

Senior R&amp;D Engineer &ndash; Galway Permanent Role Medical DeviceWhat You&rsquo;ll Do&bull; Drive all phases of product development&mdash;from concept generation and feasibility through design verification, validation, and final commercialization. &bull; Develop new medical device solutions starting from clinical needs identification through to working prototypes and commercially viable products. &bull; Partner with physicians to translate clinical insights into practical and innovative product requirements and design concepts. &bull; Contribute to technical innovation across the R&amp;D team, actively identifying and mitigating risks throughout the design process. &bull; Apply strong knowledge of anatomy and physiology, coupled with expertise in engineering principles, materials, and processes to deliver functional designs. &bull; Collaborate effectively with cross-functional teams, suppliers, and global stakeholders to support seamless development and integration. &bull; Provide hands-on engineering input, with strong involvement in technical tasks&mdash;this is an on-site role, ideally 4&ndash;5 days per week. &bull; Support the improvement of existing products and contribute to sustaining engineering activities. &bull; Participate in intellectual property generation through invention disclosure and patent applications. &bull; Mentor and guide junior engineers by providing project direction and technical oversight (no direct people management). &bull; Actively participate in peer design reviews and help drive engineering best practices across the team. &bull; Be available for travel up to 10&ndash;25%, which may include quarterly trips to the US (Minnesota, California), though travel may vary depending on project needs.What We&rsquo;re Looking For&bull; Level 8 degree in Mechanical Engineering, Biomedical Engineering, or a related discipline. &bull; Minimum 4 years of relevant engineering experience in the medical device industry. &bull; Proven track record of success in product development, from early concept through to launch. &bull; Experience in all phases of product development including initial concept, design freeze, verification, validation, and commercialization. &bull; Ideally experienced in intellectual property and patent activities. &bull; Strong team player who thrives in a cross-functional, collaborative environment and demonstrates initiative in problem-solving. &bull; Experience with Design of Experiments (DOE), Design for Manufacturability (DFM), and Six Sigma methodologies. &bull; Skilled in engaging with physicians or clinicians and incorporating clinical feedback into design iterations. &bull; Excellent communication and interpersonal skills with the ability to influence across organizational boundaries.

Senior Research and Development Engineer 

The R&amp;D Engineer will play a key role in the design, development, and testing of medical devices and systems. Focus will be on learning, developing technical skills, and applying knowledge.&nbsp;Responsibilities<ul><li>Works on well-defined tasks and projects with guidance from senior engineers or managers</li><li>Support the design and development of products including a high-level of design feasibility, prototype development, design, test method development, design verification/validation, and product commercialization&nbsp;</li><li>Application of both new and existing technologies, materials, and processes to deliver a product Supports the creation of engineering specifications, drawings, and prototypes</li><li>Ability to learn CAD Software (i.e. Solidworks) to develop and design concepts, components, and systems</li><li>Develop prototypes and conduct hands-on testing to evaluate functionality and durability Support feasibility studies and risk assessments to ensure products meet regulatory requirements, performance specifications, and safety standards Support testing protocols to validate device performance against design specifications</li><li>Understanding of problem-solving behaviors and activities such as Root Cause Analysis, Design of Experiments (DOEs), and other problem-solving tools</li><li>Conduct analysis of data and develop detailed reports and recommendations</li><li>Collaborate with clinicians and end-users to gain an understanding of their needs.</li><li>Support the creation of user needs and ensure the optimization of product functionality and performance based upon their feedback.</li><li>Prepare technical documentation in accordance with regulatory and design control requirements</li><li>Develop and maintain relationships with cross-functional team members (i.e. marketing, design assurance, global engineering, operations, project management, clinical)</li><li>Analyze existing devices and processes to identify opportunities to enhance customer needs, quality, cost, and/or production</li></ul>Educational And Experience Requirements<ul><li>Bachelor&rsquo;s degree in Science related discipline and minimum 2-5 years of experience OR Master&rsquo;s Degree in Science or Engineering preferred Experience in Research &amp; Development, ideally in medical device industry</li><li>Experience in project management</li><li>Experience in quality</li></ul>Specialized Skills/Technical Knowledge <ul><li>Solid understanding and capable of designing and developing medical devices across various stages (concept, prototyping, testing, production)</li><li>Some experience with Design Controls including documentation of design history files (DHF), risk management files, failure mode effects analysis (FMEA), traceability matrices, and verification and validation (V&amp;V) processes</li><li>Ability to learn, execute tasks, and build experience Familiarity with ISO 13485 (Quality Management System for Medical Devices)</li><li>Experience with prototyping</li><li>Effective verbal and written communication skills both Lithuanian and English Experience collaborating across multidisciplinary teams (marketing, design assurance, engineering, operations, regulatory, clinical, etc.)</li></ul>

Research and Development Engineer II

I specialise in talent acquisition for diverse industries across Ireland. With a robust experience spanning over three decades, HERO Recruitment has earned a stellar reputation for our unwavering passion and commitment to excellence.
Our client portfolio is broad, covering sectors such as medical devices, pharmaceuticals, manufacturing, IT, and more. Armed with extensive connections, I can confidently locate the perfect match for you.
However, let's shift the focus to you &ndash; your dreams and goals are my driving force. Beyond being a recruiter, I am your dedicated partner, ready to guide you through every step of your journey. Together, we will navigate through various opportunities and transform your career aspirations into reality.
Join the HERO Recruitment family today, and let's co-create a success story that is uniquely yours. Together, we will make a substantial impact in the industry. Are you ready? Let's make it happen.

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HVAC Validation Engineer

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HVAC Validation Engineer

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