Senior NPD Program Manager Galway | Permanent, Full-Time |&nbsp;
HERO Recruitment is partnering with a global medical device contract development and manufacturing company to hire a Senior NPD Program Manager for its Galway site. Reporting to the NPD Director, you will lead customer development programmes for Class II and Class III medical devices from concept through to commercial, acting as the main point of contact for the customer throughout.
The role
<ul dir="ltr">
<li>Own the customer relationship on assigned programmes, leading meetings, technical reviews and project updates.</li>
<li>Lead cross-functional teams through all phases of development, including design reviews, verification, validation and design transfer.</li>
<li>Manage project scope, schedule, budget, resources and risk, with clear reporting to customers and internal stakeholders.</li>
<li>Develop and negotiate Statements of Work, and manage scope changes through delivery.</li>
<li>Support the Business Development team with opportunity assessments, proposals and customer visits.</li>
<li>Ensure compliance with FDA Design Controls and ISO 13485.</li>
</ul>
What you will bring
<ul dir="ltr">
<li>A degree in Engineering or a related technical discipline.</li>
<li>10+ years' experience in the medical device industry, including Class II and Class III device development.</li>
<li>Proven expertise in catheter-based devices (balloon catheter and/or braided shaft technologies).</li>
<li>Significant customer-facing experience, including technical presentations and stakeholder management.</li>
<li>Experience leading design verification and validation activities.</li>
<li>A track record of managing project scope, budgets and resources, and of developing Statements of Work.</li>
<li>CDMO experience and a PMP or equivalent certification are an advantage.</li>
</ul>
To apply or find out more, contact Dee Curley at HERO Recruitment on <a href="mailto:dee@hero.ie" target="_blank" rel="noopener">dee@hero.ie</a> or 086 7902191.

Program Manager - NPD 

Senior NPD Engineer 
Location: Galway, Ireland 
Reports To: Director, NPD 
Type: Full-time
Our client, a leading medical device manufacturer, is seeking a Senior NPD Engineer to provide technical leadership for development programs throughout the NPD lifecycle. Acting as technical lead, you'll be responsible for engineering execution and technical decision-making, ensuring products are developed in accordance with customer, regulatory, quality, and manufacturing requirements. You'll serve as the primary technical interface with customers, leading technical discussions, design reviews, and problem-solving activities, while partnering with the Program Manager on project planning, budgeting, and risk management. The role also provides leadership, coaching, and mentoring to engineers and technicians, and may carry direct people management responsibility.
Key Responsibilities
<ul dir="ltr">
<li>Lead the technical execution of product development programs from feasibility through manufacturing transfer.</li>
<li>Act as the primary technical interface with customers, building strong relationships and providing technical leadership throughout the development process.</li>
<li>Lead technical reviews, design reviews, risk assessments, and problem-solving activities with customers and internal teams.</li>
<li>Own technical strategy, design decisions, and engineering execution for assigned projects.</li>
<li>Ensure products and associated processes are developed in accordance with customer requirements, Design Controls, regulatory standards, and business objectives.</li>
<li>Partner with Program Managers on project planning, budgeting, resource allocation, and risk management.</li>
<li>Identify, assess, and mitigate technical risks throughout the product development lifecycle.</li>
<li>Drive development activities through verification, validation, design transfer, and commercialisation.</li>
<li>Collaborate with customers and internal stakeholders (Manufacturing, Quality, Supply Chain) to achieve successful project outcomes.</li>
<li>Support manufacturing scale-up, product transfer, and post-commercialisation activities.</li>
<li>Provide leadership, coaching, and technical guidance to engineers and technicians; may have direct people management responsibility.</li>
<li>Maintain accurate technical documentation and development records throughout all stages of product development.</li>
</ul>
Qualifications &amp; Experience
<ul dir="ltr">
<li>Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering, or a related discipline.</li>
<li>Minimum 7 years of medical device product development experience.</li>
<li>Demonstrated experience leading development projects throughout the product development lifecycle.</li>
<li>Experience working within Design Control and regulated medical device environments.</li>
<li>Proven customer-facing experience with responsibility for technical discussions and project leadership.</li>
<li>Experience leading, mentoring, or managing engineers and technical teams.</li>
<li>Working knowledge of Design Controls, Risk Management, Verification &amp; Validation, and Design Transfer.</li>
<li>Knowledge of applicable medical device regulations and standards, including ISO 13485 and FDA requirements.</li>
<li>Experience with catheter-based, balloon catheter, or delivery system technologies is an advantage.</li>
</ul>
For further information on this role please contact Gavin Moran on 087 4108620 or <a href="mailto:connect@hero.ie" target="_blank" rel="noopener">connect@hero.ie</a> Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/" target="_blank" rel="noopener">https://www.hero.ie/</a> 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 your application.

Senior NPD Engineer

Validation Supervisor
Our client, a leading medical device manufacturer, is seeking a Validation Supervisor to lead a site-based team of Validation Quality Engineers. This role is accountable for the effective planning, coordination, and execution of equipment and process validation activities supporting new product introductions, change control, and strategic initiatives. You'll partner closely with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure validation activities are executed in compliance with the Quality Management System and applicable regulatory requirements, playing a critical role in maintaining a compliant validated state.
Key Responsibilities
<ul>
<li>Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring, and performance guidance.</li>
<li>Plan and coordinate execution of equipment, process, and test method validations supporting new product development, change control, and strategic initiatives.</li>
<li>Ensure validation activities are performed in accordance with internal procedures, regulatory requirements, and industry best practices.</li>
<li>Review and approve validation documentation, including validation plans, risk assessments, protocols, reports, and deviation or exception documentation.</li>
<li>Allocate resources and manage timelines to support project schedules and operational priorities.</li>
<li>Act as site validation liaison with Design Assurance, R&amp;D, Engineering, Manufacturing Operations, Supply Chain, and Quality functions.</li>
<li>Support compliance activities including internal audits, inspections, and CAPA processes.</li>
<li>Identify and drive continuous improvement opportunities related to validation processes, standard work, and compliance practices.</li>
<li>Apply problem-solving, critical thinking, and risk-based decision-making in a dynamic manufacturing environment.</li>
<li>Communicate complex technical information clearly to diverse stakeholders, including senior leadership.</li>
</ul>
Qualifications &amp; Experience
<ul>
<li>Bachelor's degree in Engineering, Science, or a related discipline, or equivalent experience.</li>
<li>8&#150;12 years' experience in validation, quality engineering, or a related role within a regulated industry.</li>
<li>Demonstrated experience working in medical device, pharmaceutical, or similarly regulated manufacturing environments.</li>
<li>Prior experience leading or supervising technical or quality teams is required.</li>
<li>Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related regulatory standards.</li>
<li>Experience with statistical analysis and validation tools.</li>
<li>Demonstrated experience supporting audits and regulatory inspections.</li>
<li>Certified Quality Engineer (CQE) or equivalent professional certification is an advantage.</li>
</ul>
For further information on this role please contact Gavin Moran on 087 4108620 or connect@hero.ie
Check out all our open jobs on our HERO Recruitment website &#150; 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 your application.

Validation Supervisor 

Summary
The Senior Engineer, Moulding provides technical leadership for injection moulded components, tooling, and manufacturing processes across global operations. The role partners with Engineering, Operations, Research and Development, New Product Development, Quality, Supply Chain, and external suppliers to support product and process development, validation, commercialization, and continuous improvement. The position leads complex technical projects, drives robust moulding solutions, manages supplier and tooling activities, and ensures the successful introduction and optimization of validated manufacturing processes.
Responsibilities
<ul>
<li>Lead and influence cross-functional and geographically dispersed teams to achieve project objectives and business priorities.</li>
<li>Manage technical projects from concept through implementation, including scope, schedules, budgets, risks, resources, and deliverables.</li>
<li>Partner with stakeholders across Engineering, Operations, Quality, Supply Chain, Research and Development, and New Product Development to support product lifecycle activities.</li>
<li>Provide technical expertise in injection moulding, tooling, component development, and process validation.</li>
<li>Lead supplier identification, selection, qualification, and ongoing performance management activities.</li>
<li>Develop and maintain component specifications, technical drawings, models, process documentation, and validation records.</li>
<li>Plan and execute prototype, pilot, and proof-of-concept activities to evaluate designs and manufacturing approaches.</li>
<li>Apply scientific and data-driven methodologies, including design of experiments and process optimization techniques, to improve process capability and performance.</li>
<li>Oversee mould design, build, qualification, and implementation activities.</li>
<li>Assess impacts of component changes on manufacturing systems and coordinate required equipment modifications and validations.</li>
<li>Support the introduction of new products, technologies, and process improvements into manufacturing environments.</li>
<li>Monitor project performance using defined metrics and implement corrective actions as needed.</li>
<li>Maintain awareness of industry, regulatory, and technology developments relevant to the role.</li>
<li>Communicate effectively through verbal, written, and presentation-based methods.</li>
<li>Use computer systems and standard business software to perform daily responsibilities.</li>
<li>Participate in meetings, project reviews, manufacturing assessments, and collaborative activities.</li>
<li>Travel domestically and internationally as required to support projects, suppliers, and business operations.</li>
<li>Perform occasional physical activities associated with engineering and manufacturing environments, including walking, bending, climbing, and lifting materials or equipment up to approximately 15 pounds.</li>
<li>Provide schedule flexibility when required to support critical project implementation activities.</li>
</ul>
Essential Functions of the Role
<ul>
<li>Communicate effectively via email, phone, and virtual platforms.</li>
<li>Collaborate across departments to support organizational goals.</li>
<li>Ensure data accuracy and confidentiality in compliance with company and legal standards.</li>
<li>Lead or support special projects aligned with departmental objectives.</li>
<li>Travel frequently, including overnight and occasional weekend travel.</li>
<li>Occasional lifting of materials up to 15 pounds may be required.</li>
<li>Communicate with supervisors and team members to coordinate workflow.</li>
<li>Support product development and design assurance.</li>
<li>Participating in cross-functional project teams.</li>
<li>Ensuring adherence to regulatory standards (e.g., EU MDR, FDA).</li>
<li>Education &amp; Work Requirements</li>
<li>Bachelor&#146;s Degree with 5-8 years of related experience</li>
</ul>
Education &amp; Work Preferences
<ul>
<li>Bachelor&#146;s degree in Engineering or a related technical discipline.</li>
<li>Minimum of 5 years of experience in injection moulding, tooling, process development, manufacturing engineering, or a related field.</li>
<li>Minimum of 3 years of experience leading or managing technical projects.</li>
<li>Demonstrated expertise in injection moulding processes, tooling, qualification, and validation activities.</li>
<li>Experience with CAD software and technical documentation development.</li>
<li>Knowledge of project management principles, supplier management, budgeting, and cost control.</li>
<li>Strong analytical, problem-solving, technical writing, and communication skills.</li>
<li>Proficiency with Microsoft Office and standard business applications.</li>
<li>Advanced degree in Engineering or a related discipline.</li>
<li>Hands-on experience in mould making, process development, and high-volume manufacturing environments.</li>
<li>Experience with scientific moulding methodologies, design of experiments (DOE), design for manufacturability (DFM), and statistical analysis tools.</li>
<li>Proficiency with 3D CAD applications, including SolidWorks.</li>
<li>Experience working with highly automated manufacturing systems and global cross-functional teams.</li>
</ul>

Senior Moulding 

<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Engineering Manager - Co Sligo&nbsp;
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Our clients mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.&nbsp; We have an exciting opportunity for Engineering Manager, this is a varied engineering leadership role supporting safe, compliant and reliable manufacturing operations. We welcome candidates with experience in pharmaceutical, biotechnology, chemical processing or other highly regulated manufacturing environments, including those with a background in solvent handling, chemical process operations, hazardous-area engineering or complex process equipment.
In this role you will: 
<ul>
<li>Establish departmental goals, schedules and activity plans in partnership with the Operations Engineering Manager.</li>
<li>Lead, support and develop the API Engineering team, creating an inclusive environment where people can perform at their best.</li>
<li>Support the development, maintenance and improvement of manufacturing equipment.</li>
<li>Ensure equipment performance meets applicable legal, divisional, corporate, quality and safety standards.</li>
<li>Develop and implement appropriate CAPA plans, including clear actions, owners and timelines.</li>
<li>Lead investigations and equipment-monitoring activities to improve manufacturing performance, reduce downtime and maximise plant output and yield.</li>
<li>Drive equipment and process upgrades within a continuous improvement environment.</li>
<li>Develop monthly engineering metrics and provide timely management reports.</li>
<li>Manage engineering budgets and prepare capital expenditure requests as required.</li>
<li>Support successful internal, external, divisional and corporate audits.</li>
<li>Promote safe working practices and ensure compliance with site and company safety standards.</li>
<li>Manage internal and external engineering and plant projects.</li>
</ul>
Ideally you will have: 
<ul>
<li>Degree qualification or above in Chemical Engineering, Chemistry or a related scientific or engineering discipline.</li>
<li>7 &#150;10 years&#146; experience in the pharmaceutical industry, including at least two years in an engineering supervisory or management role.</li>
<li>Demonstrated ability to lead, coach and develop people.</li>
<li>Previous experience in pharmaceutical, biotechnology is preferred. Experience supporting API manufacturing operations would be an advantage but is not essential.</li>
<li>Experience leading engineering activities that support manufacturing operations, equipment reliability, maintenance, projects or continuous improvement.</li>
<li>Experience with solvent handling, chemical processing, hazardous materials or complex process systems is highly relevant.</li>
<li>Excellent problem-solving skills and the ability to make timely, well-informed engineering decisions.</li>
<li>Strong communication and relationship-building skills, with the ability to work effectively across technical and non-technical teams.</li>
<li>Experience managing projects, budgets, contractors and cross-functional team.</li>
<li>Experience managing projects, budgets, contractors and cross-functional stakeholders <span style="color: #000000; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; font-family: arial, helvetica, sans-serif; font-size: 10pt;">To discuss this and other roles call Regina Carroll at 086 0100903&nbsp;or email&nbsp;<a href="mailto:engineering@hero.ie" target="_blank" rel="noopener">jobs@hero.ie</a><br style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"><br style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"><span style="color: #000000; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; font-family: arial, helvetica, sans-serif; font-size: 10pt;">Check out all our open jobs on our HERO Recruitment website &#150;&nbsp;<a href="https://www.hero.ie/" target="_blank" rel="noopener">https://www.hero.ie/</a><br style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"><br style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"><span style="color: #000000; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; font-family: arial, helvetica, sans-serif; font-size: 10pt;">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 </li>
</ul>

Engineering Manager

Product Development Scientist I - Graduate Entry&nbsp;
Location - Tuam, Co. Galway
Function - R&amp;D
1. Job Purpose
As part of the R&amp;D team in Transitions Optical, you will be responsible for implementing new technologies and methodologies as part of research and development of new photochromic coating products. You will work as part of the functional team by driving individual input, and contributing to delivering the overall groups&#146; objective. Embedded in a global and cross-functional team, you will contribute to the effective problem solving and technology transfer from R&amp;D to the manufacturing facilities to complete the industrialization and commercialization of our products.
2. Key Responsibilities of the Role
<ul>
<li>Works independently and understands fundamental principles of technology</li>
<li>Uses the principles of technology to design effective experiments for formulation and process with input</li>
<li>Has ability to analyse data, make data driven decisions</li>
<li>Effectively uses root cause analysis for a variety of solutions</li>
<li>Demonstrates the ability to successfully overcome obstacles and challenges in pursuit of objectives.</li>
<li>Begins to create partnerships with relevant stakeholders within their function.</li>
<li>Collaborates and cooperates with team members to get the job done.</li>
<li>Takes calculated risks related to own role.</li>
<li>Anticipates the impact of decisions on other individuals.</li>
<li>Uses concrete and objective facts in decision-making whenever possible.</li>
<li>Effectively uses feedback in their development plans.</li>
<li>Learns from senior managers and experts and seeks guidance from others as appropriate.</li>
<li>Makes suggestions to others for increasing the effectiveness of change within the department using technical knowledge.</li>
<li>Presents information to influence long-term strategies and decisions to leadership.</li>
<li>Documents work in reports, papers and presentation with little oversights or editing.</li>
<li>Develops authenticity and effectiveness in their communication style. Demonstrates the ability to influence others.</li>
<li>Further develops network and relationships with cross-functional team</li>
</ul>
3. Key Requirements (Education and Experience)
<ul>
<li>Level 8: Honours Bachelor Degree (HETAC) in relevant field with minimum 1 year industry experience</li>
<li>Must be hands-on with laboratory work and process development</li>
<li>Has the capability to easily change direction if required.</li>
<li>Has a strong and positive work ethic</li>
<li>Must be able to work both individually and as a part of the team with a strong work relationship</li>
<li>Strong time management skills</li>
</ul>
4. Transversal Responsibilities
<ul>
<li>All employees have a responsibility to contribute to the Groups sustainability and in doing so ensure that we can continue to fulfil our mission.</li>
<li>All business decisions and actions must serve and be in line with the Groups sustainability goals and mission.</li>
<li>An employee must abide by the legal compliance policy in the performing of their duties.</li>
</ul>

Product Development Scientist I

Hey there! As an experienced recruitment consultant with a solid track record in the industry. I've got the skills and expertise to make those perfect connections. My experience spans various industries, such as medical devices, pharmaceuticals, Fintech, Medtech, IT, and automotive. Talk about a wide range! My passion for learning knows no bounds. I'm always seeking new knowledge and continuously studying to stay ahead of the game. Because let's face it, staying up-to-date is crucial in this fast-paced world.
As someone who values hard work, I understand the importance of finding a place that respects not only your professional expertise but also who you are as a person. It's all about finding that perfect match where you feel valued and appreciated.
Outside of work I love music and festivals. You might be wondering how that ties into my recruitment work, but here's the thing&mdash;music and festivals are all about creating incredible experiences, bringing people together, and fostering a sense of community. These values align perfectly with my approach to recruitment. I believe in creating meaningful connections, understanding the unique qualities and passions of candidates, and finding the perfect fit where they can thrive and contribute.
If you have any questions about the roles I'm advertising or need assistance with your hiring needs, don't hesitate to reach out. I'm here to guide you, connect the dots, and make your recruitment journey smooth and successful.

Job Details

Program Manager - NPD

Recruitment Consultant