15 Johnson Johnson jobs in Ireland

Overview The purpose of this role is to work as part of the Research and Development team in the design, development and taking to market of medical devices for the Cook Medical. Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities Perform Duties of Senior Research and Development Engineer: Design development Prototyping and test method design. Design and/or process evaluation, reviews, specifications, verification and validation, protocols and reports and transfer to production activities in a timely and effective manner. Product and project risk analysis and risk management. Develop prototypes which are consistent with the clinical and design requirements of the project. Research new therapies and design solutions to develop and complement the existing product portfolio. Introduce new equipment, materials and technologies. Generation of Design History File documentation. Support of regulatory submissions. Work closely with Key Opinion Leaders (KOL's), physicians and product managers to develop innovative medical devices to improve patient care. Project lead for assigned Research and Development team/s including technical and project management leadership responsibly. Lead technical development of projects. Lead all key design decisions to ensure quality design selection. Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved. Work closely to build effective relationships with cross functional groups to achieve project and company goals. Retrospective project reviews to understand lessons learned. Manage device evaluations. Compliance with Quality, Regulatory and company policies and systems. Mentoring, coaching and development of team members if required. Foster innovation and creativity within team and perform disclosure reviews. Ensure compliance with Quality, Regulatory and company policies and systems. Communications: Regular communication to cross-functional teams, senior management and business unit leaders. Project status communications and reporting. Remain on the forefront of emerging industry practices. Instrumental in driving and implementing change to improve departmental and company performance. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Act as a designee for the Manager, Research and Development or Team Lead, Research and Development. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree required, preferably in engineering or a related field. Minimum of 5 years' relevant experience is required. Experience in Product Development projects within Medical Device or regulated industry/adjacent experience. Proven project/technical experience. Project management methodology and skills. Proven experience working closely with project managers. Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards. Strong statistical understanding and experience e.g. DOE and/or Gage R&R. Strong technical writer. Good working knowledge of Solidworks and/or Pro Engineer CAD. Experience of medical device development from concept through to commercialisation. Ability to effectively translate needs of clinicians and Strategic Business Unit into project inputs. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #IrishJobs To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.

Overview The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical. Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities Perform Duties of Research & Development Engineer 2: Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner. Product testing and evaluation, completion of test reports to support design selection. Preparation and presentation of design reviews. Product risk analysis and risk management. Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques. Source new materials components and equipment. Development of component specifications, inspection methods, bills of materials and manufacturing processes. Introduction of new equipment, materials and technologies. As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care. Work closely with Project Lead and take responsibility for assigned research and development project tasks: Manage and drive assigned project tasks to ensure timely completion of project milestones. Work closely with cross functional groups to achieve project and company goals. Product performance evaluations. Contribute to innovation and creativity within team through filing of disclosures and patents. Hold regular project meetings and document minutes and actions. Ensure project milestones are achieved to meet business metrics. Communications: Regular communication to cross-functional teams and senior management. Project status communications and reporting. Remain on the forefront of emerging industry practices. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree is required, preferably in engineering or a related field. Minimum of 3 years' relevant experience is desired. Project planning/execution skills. Execution of project in a timely effective manner. Knowledge of anatomy and physiology. Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge. Statistical understanding and experience. Manufacturing design and process understanding. Good working knowledge of Solidworks and/or Pro Engineer CAD. Strong technical writer. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The MedSurg R&D team in Limerick has two programs, Endoscopy/EndoSurgery and Otolaryngology Head and Neck Surgery (OHNS) that it is responsible for designing and developing new and innovative products for. The R&D engineers and scientists have the opportunity to explore and create novel ideas within feasibility, bring a medical device through verification and validation phase and be a part of bringing a new product to the market. The MedSurg R&D team works in collaboration with Cook's sister site in Winston Salem, North Carolina. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.

Join the Frontlines of Surgical Innovation - Territory Manager (Surgical) Territory: Dublin & South/South East Ireland About the Company Our client is a leading player in the medical distribution sector, known for delivering innovative healthcare solutions across Ireland and beyond. With a strong reputation for excellence, they partner with world-class suppliers to bring cutting-edge surgical and medical technologies to hospitals and healthcare providers. Their team is driven by a shared commitment to improving patient outcomes, supporting clinical excellence, and fostering long-term customer relationships. This is a company where your expertise will be valued, your ideas welcomed, and your career supported through continuous development and meaningful work. If you're looking to join a forward-thinking organisation that's shaping the future of healthcare, this is the opportunity for you. What You'll Be Doing Drive Revenue Growth: Own your territory and exceed monthly revenue and margin targets. Strategic Sales Planning: Forecast demand, manage pipeline reports, and execute account plans. Customer Engagement: Build strong relationships with hospitals, clinicians, and procurement teams. Supplier Collaboration: Work closely with global suppliers to resolve customer issues and stay ahead of market trends. Industry Presence: Represent the brand at trade shows, conferences, and training workshops. Some in In theatre support (elective) Your Territory Covering key regions including South Dublin, Cork, Waterford, Wexford, Kilkenny, Clonmel, and Laois. You'll be on the move, engaging directly with customers and occasionally traveling to the UK and EMEA for supplier meetings and industry events. Candidate would be ideally placed in Dublin or surrounding areas. What We're Looking For Experience: 2+ years in medical device sales, ideally in surgical or theatre environments, though not a necessity. Track Record: Proven success in the Irish medical market, especially with procurement teams. Knowledge: Strong grasp of clinical and technical detail, with the ability to communicate fluently with healthcare professionals. Tech Savvy: Comfortable with Outlook, Word, Excel, and CRM tools (Salesforce experience a plus). Education: Degree in a scientific, medical, or business discipline preferred. Personal Attributes Exceptional communication and influencing skills Customer-first mindset with a passion for delivering value Commercially astute with a hunger for business growth Self-motivated, dynamic, and solution-oriented Organised and able to prioritise effectively Full driving license required Why This Role? This is more than just a sales job. It's a chance to be part of a high-performing team that's transforming surgical care across Ireland. If you're enthusiastic, strategic, and ready to make a difference, we want to hear from you. Competitive base salary, bonus, pension, lunch allowance and company car Ready to take the next step in your career? Apply now and become a key player in shaping the future of surgical innovation. Adecco Ireland is acting as an Employment Agency in relation to this vacancy. Skills: surgical sales medical Benefits: Work From Home pension bonus company car

Medical Device Product Specialist | Nationwide (Ireland)

Are you a confident communicator with a passion for healthcare and innovation? A dynamic opportunity awaits for an ambitious individual to join a forward-thinking medical device organization as a Medical Device Product Specialist . If you're driven by results, eager to grow your career, and excited to work at the intersection of science, technology, and patient outcomes — this could be your next big move.

The Ideal Candidate :

All candidates must hold a third-level qualification (minimum: NFQ Level 8 – Honors Bachelor Degree) and ideally bring 3+ years of experience from one or more of the following areas:

• Healthcare (clinical, surgical, or healthcare-related background – an advantage, but not essential as training is provided)

• Business (B2B Sales, Marketing, Finance, Accounting, Commerce)

• Engineering (Biomedical, Biochemical)

• Science (Microbiology, Biochemistry, Neuroscience, Mathematical Sciences, Biology, R&D)

Our Client is looking for someone who:

• Is a self-starter with an entrepreneurial drive and a hunger to succeed.

• Has a natural flair for presenting, with the ability to communicate complex technical information in an engaging, relatable way.

• Approaches challenges with a solution-focused mindset and thrives under pressure.

• Enjoys building genuine relationships and sees value in long-term client trust.

• Is eager to continuously learn, grow, and evolve within a commercial healthcare setting.

Responsibilities include but are not limited to:

• Setting and achieving territory business development goals and sales targets

• Promoting a portfolio of surgical devices and healthcare solutions to medical professionals

• Building and maintaining strong customer relationships based on credibility and trust

• Gathering and sharing market intelligence, including customer feedback, competitor activity, and emerging opportunities

• Representing the brand at meetings, product demonstrations, workshops, and industry events

• Collaborating with internal teams to ensure high levels of customer service and operational excellence

• NFQ Level 8 Honours Bachelor Degree in a relevant discipline (Healthcare, Business, Engineering, or Science)

• Minimum 3 years of experience in a relevant industry

• Strong interpersonal, communication, and public speaking skills

• Proven ability to manage a territory and work autonomously

• Full, clean driving licence (essential)

• Must be currently residing in Ireland

• Willingness to travel nationwide

• A long-term vision to develop within the healthcare sales and marketing field

What’s on Offer: Competitive base salary with bonus structure; Company car, expenses, and pension contribution ; Comprehensive training and onboarding; Supportive team culture focused on innovation and continuous improvement; Opportunity to join a growing company and make a real impact in the medical device sector

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

 Pale Blue Dot® Recruitment

The Experts in STEM Workforce Solutions

I am keen to speak with R&D Engineers who are looking to further develop their career in the Design and Development of Medical Device Products. Leading R&D Projects at my clients state of the art Medical Device Design Facility, you will work in cross-functional teams based in Ireland and liaise with other R&D Teams Internationally. I currently have a role for a Senior R&D Engineer (€85k+). As well as offering a competitive packages (€ my client has an award-winning culture and at ISS Ltd (Recruitment Agency) we are offering Signing Bonuses ( and Relocations Packages ( - ) for this position APPLY TODAY R&D Engineer / Research & Development / New Product Development / Design Controls / Material Science Engineer / New Product Introduction / R&D / AutoCAD / 3D Modelling / Medical Device / Mayo / Ireland Independent Search Solutions Agency are happy to offer a Relocation Package for Candidates based in Ireland, UK & EU who need to move to the area (County Mayo, Ireland) Job Title: Lead R&D Engineer (Final Stage Development) Location: Co. Mayo Package: Full Time / Permanent (Min, 40% On-Site) k+ Basic Annual Bonus (7.5% - 10%) Health Insurance (VHI) Pension Parking Canteen Paid Annual Leave Relocation Package ( - ) Signing Bonus ( Role: The Lead R&D Engineer will have with extensive research & development experience; and will be capable of utilizing their expertise and skills in the successful development of new products. They will be capable of identifying and investigating new product ideas or technologies and bringing these through a defined technology development process. They will build prototypes, collect user feedback, and conduct experimentation and data analysis to optimize and refine product concepts and perform verification and validation of product designs. You will be capable of serving as a leader in a collaborative and cross functional environment for the successful completion of project goals and will be capable of interfacing with senior management within the organization. Duties: Representing R&D on New Product Development project teams Researching new ideas and technologies/materials and evaluating technology performance and stability Sourcing/selecting materials and components and the evaluation of same Developing product and component specifications to ensure that the product consistently performs to a level which meets the needs of the customer Developing new test methods to characterize and measure the performance of the product Providing technical R&D support to other functions including Global Marketing, Regulatory Affairs, Engineering and Manufacturing Managing project schedules, conducting product and project risk analysis and ensuring successful and timely completion of project activities Working with patent counsel to support patentability/infringement searches and preparation of patent applications Creating relevant design documents including technical reports, drawings, specifications Planning and performing design verification and design validation activities Company: An established Multinational with Manufacturing and R&D facilities on-site in Ireland. Manufacturing a range of disposable Medical Device Products used across the Healthcare Sector. Experience: Third Level Degree (Hon) in Mechanical / Biomedical Engineering 7-8 Years commercial experience in a R&D role (Medical Device Industry) Skills Matrix: Innovative / Creative Thinker; must have a demonstrated ability to conduct exploration of subject areas for novel concepts and approaches Working knowledge of AutoCAD and 3D modelling software Demonstrated analytical problem-solving abilities Demonstrated ability to manage projects including directing the work of others Good team working skills and a high level of enthusiasm and motivation Good working knowledge of medical device quality & regulatory systems and medical device directives If you would like to be considered for this opportunity, follow the links below and send me your CV. Key Words: R&D Engineer / Research & Development / New Product Development / Design Controls / Material Science Engineer / New Product Introduction / R&D / AutoCAD / 3D Modelling / Medical Device / Mayo / Ireland Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place, you can be assured that your details will not be shown to any of ISS Ltds clients without your consent. Skills: Medical Device R&D Engineer Research And Development Material Science Engineer New Product Development AutoCAD Prototype Development 3D Modelling Benefits: Annual Bonus / 13th Cheque Group Life Assurance Medical Aid / Health Care Pension Fund Performance Bonus Work From Home Relocation Assistance

I am keen to speak with R&D Engineers who are looking to further develop their career in the Design and Development of Medical Device Products. Working on R&D Projects at my clients state of the art Medical Device Design Facility, you will work in cross-functional teams based in Ireland and liaise with other R&D Teams Internationally. I currently have a range of roles from Engineer Level (€65k) to Senior Engineer Level (€5k+). As well as offering competitive packages ( my client has an award-winning culture and at ISS Ltd (Recruitment Agency) we are offering a Signing Bonus ( APPLY TODAY R&D Engineer / Research & Development / Improve Current Product Design / NPD / Design Controls / Material Science Engineer / Hydrophilic Coated Products / Polymer Science / Medical Device / Mayo / Ireland Job Title: R&D Engineer Location: Co. Mayo Package: Full Time / Permanent k - k Basic Annual Bonus (7.5% - 10%) Health Insurance (VHI) Pension Parking Canteen Paid Annual Leave Signing Bonus ( Role: The R&D Engineer is expected to help drive the development and integration of new materials, processes or technologies into new products and processes. You will have a good understanding of medical device design controls, be capable of participating in cross-functional teams and interfacing with colleagues at all levels within the organization while effectively delivering solutions which benefit our customers. Duties: Providing technical support to NPD, Global Marketing, Engineering and Manufacturing Leading or supporting project teams to select and demonstrate the feasibility of alternative materials, processes or technologies for new and existing products Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes Working with cross functional partners to gather stakeholders input and develop plans to ensure requirements are assessed and met by proposed technical solutions Developing protocols and experimental test plans and managing the product build, transportation and storage as well as the execution of testing Conducting statistical analysis of data and developing detailed reports documenting results, conclusions and recommendations Representing the Research & Development function on cross-functional teams throughout the New Product Commercialization process Company: An established Multinational with Manufacturing and R&D facilities on-site in Ireland. Manufacturing a range of disposable Medical Device Products used across the Healthcare Sector. Experience: Third Level Degree (Hon) in Materials / Polymer Science / Mechanical / Biomedical Engineering 3-5 Years commercial experience in a R&D role (Medical Device Industry) An understanding of hydrophilic coatings and related technologies Skills Matrix: Attention to detail and good understanding of design controls and associated documentation A demonstrated track-record of being part of successful cross-functional technical teams Innovative / Creative Thinker; must have a demonstrated ability to conduct exploration of subject areas for novel concepts and approaches Demonstrated analytical problem-solving abilities Demonstrated ability to manage projects including directing the work of others Good team working skills and a high level of enthusiasm and motivation Good working knowledge of medical device quality & regulatory systems and medical device directives Experience of hydrophilic coating technologies, materials science and surface chemistry If you would like to be considered for this opportunity, follow the links below and send me your CV. Other R&D Roles @ ISS Ltd: Snr R&D Team Lead / k+ R&D Project Manager / k+ Key Words: R&D Engineer / Research & Development / Improve Current Product Design / NPD / Design Controls / Material Science Engineer / Hydrophilic Coated Products / Polymer Science / Medical Device / Mayo / Ireland Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place, you can be assured that your details will not be shown to any of ISS Ltds clients without your consent. Skills: R&D Engineer Material Science Hydrophilic Coating Technology Design Controls Medical Device R&D Polymer Science R&D Benefits: Annual Bonus / 13th Cheque Group Life Assurance Medical Aid / Health Care Pension Fund Performance Bonus Meal Allowance / Canteen Study Assistance

Our client, a global medical device manufacturer, has created a new Senior Financial Analyst job on their 25 person Finance team in Galway due to continuous growth of their local operations. Its the ideal avenue into the medical device sector if you have strong finance business partnering, budgeting and forecasting experience, or it can be the perfect step-up if you are already working in the medical device industry as the scale and complexity of transactions you will manage will further develop your career. Your work as the Senior Financial Analyst will be value add, among your responsibilities will include: Preparation of the annual budget (AOP) and the 5-year strategic plan for the site in partnership with other members of the FP&A team and heads of department across site Partner with two departments on all their budgeting, forecasting, financial analysis and project accounting, helping non-Finance leaders understand cost and revenue drivers for their departments Overheads budgeting and financial analysis, with over 4,000 employees onsite youll provide deeper insights to senior leadership on spend on FTEs, agency staff, employee benefits, professional contract fees and utilities expenditure This multinational company invest in their people with multiple avenues for career progression including structured promotion opportunities that dont depend on someone higher up moving out of their role and global finance jobs come to the Galway site due to their reputation of excellence and delivery. They are at the cutting edge of innovation exemplified by having a cross-functional A.I. project team who are introducing the latest A.I. technology that automates tasks and the companys share price has grown by 150% in the last five years due to exceeding revenue targets. You will join a high-performing FP&A team who will give you all the support you need to settle into your new job and youll enjoy working with like-minded, capable colleagues. The package on offer is worth €85,000-€90,000 including base salary, annual bonus, full family health insurance, sizeable company pension contribution, share options scheme, hybrid working of 2 days per week and non-monetary benefits of working for a major brand name, significant career progression opportunities and manufacturing operations exposure. Experience To become the Senior Financial Analyst will be a qualified accountant (ACA/ACCA/CIMA) with exposure to financial or commercial analysis which informed business decision making from any sector. Apply today With your latest CV apply now or contact Shane Lynott, Talent Acquisition Manager, via the details in our bio. Skills: Finance Business Partnering Financial Planning & Analysis Benefits: Work From Home

Electronic Engineer - Medical Device Are you passionate about developing innovative medical technologies that can change lives? A leading medical device start-up is seeking an Electronic Engineer to join their growing R&D team in the development of a next-generation device. This is a unique opportunity to be a foundational team member in a high-potential, award-winning start-up environment. You will play a pivotal role in enhancing device usability, supporting high-volume manufacturing readiness, and driving the product transition from clinical development to commercial release. Key Responsibilities Design and optimise electrical architecture for wearable medical devices, integrating sensors, microcontrollers, and power circuits. Develop and validate PCB layouts for compact, low-power systems. Manage PCB manufacturing orders and ensure design for manufacturability. Conduct circuit analysis, system testing, and validation in compliance with medical device standards. Implement and refine power management strategies and wireless communication protocols (e.g., WiFi, Bluetooth, cellular). Troubleshoot issues in hardware subsystems during prototyping and production. Collaborate with firmware, mechanical, and clinical teams to deliver integrated product solutions. Maintain accurate documentation, including schematics, test procedures, and compliance reports. Minimum Qualifications Bachelor's degree in Electronic Engineering or equivalent. 5+ years' experience in hardware design for embedded systems. Proven expertise in PCB design/layout, circuit analysis, and low-power electronics. Strong understanding of hardware interfaces (ADC, DAC, GPIO, I2C, SPI, UART). Familiarity with power supply design, battery systems, and wireless communications. Experience with test tools (oscilloscopes, logic analysers, electronic loads). Strong communication skills and ability to work effectively in cross-functional teams. Fluent in English, both written and verbal. Desirable Skills Experience in wearable or medical device development. Knowledge of ECG signal acquisition and conditioning. Familiarity with EMC compliance and safety standards for regulated devices. Experience designing for manufacturability and working with PCB suppliers. Exposure to embedded C/C++ and platforms like Nordic, STM, or ESP32. What's on Offer Competitive salary (details provided during application). Benefits including pension, healthcare, and generous annual leave. Flexible work culture with the opportunity to shape the future of cardiac diagnostics. At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details. Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see Skills: Medical Device Electronics PCB Design Development Benefits: Work From Home

Principal Scientist/Engineer Medical Device Development Our Dublin based client are currently recruiting for a highly skilled Principal Scientist/Engineer to join their Device and Product Performance team on a permanent basis. In this role, you will lead the design, development, and performance evaluation of drug-device combination products, ensuring they meet regulatory and quality standards. Your expertise will drive technical excellence, innovation, and patient-centric solutions. Responsibilities Provide subject matter expertise to support the development of Combination Products Plan and execute design verification and reliability strategies Be the technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements Develop test methods and specifications to assess device functionality and product performance including evaluation, procurement & implement new, state-of-the-art lab testing equipment as applicable Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliability Ensures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management system Lead support activities for external and internal audits and inspections as applicable Requirements Degree in Science/Engineering (Masters preferred) 7+ years experience in pharmaceutical and/or medical device development Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage Experience in the development and validation of analytical methods Experienced in application of statistical techniques for data analysis Experience of writing and supporting regulatory submissions Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders Some travel will be required as part of this role For more information, please contact Sinéad Cullen on or Skills: Combination Products Design Verification Analytical Science