Purpose Boston Scientific Clonmel is hiring a Senior Process Engineer to join its Process Development Team. This role will work cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of product into production. Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Interfaces with Design, Quality and Manufacturing organizations to integrate new products, equipment sets or processes into production. Responsibilities Researches, develops, designs, and evaluates mechanical and electro‑mechanical materials, components, assemblies, processes and/or equipment. Conducts feasibility studies to verify capability and functionality. Develops new concepts from initial design to market release. Write and submit intellectual property (patents). Maintains detailed documentation throughout all phases of development. Working as part of the Process Development group this person will aid design of new equipment for new products & manufacturing. This person will play a key role in the design phase of the equipment from initialisation to final handover. Work closely with machine Vendors in order to ensure that the equipment is designed, built & tested according to Boston Scientific specifications and is properly handed over to manufacturing. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems. Plans, organizes, and conducts all aspects of technical reviews. Ensures proper documentation is completed to meet quality systems requirements (e.g., BOM’S, Routers, FMEA’S, etc.). Reviews or coordinates vendor activities to support development. Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes. Demonstrates strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA’S, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes. Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results. Demonstrates a primary commitment to patient safety and product quality. Understands and complies with all the regulations governing the quality systems. Experience with low‑pressure dispense systems and injection moulding an advantage. Qualifications/Experience Level 8 Hons Bachelor Degree (or higher) in Engineering or relevant discipline. 5+ years engineering experience in a GMP environment. Laser weld experience highly advantageous. At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com . #J-18808-Ljbffr
Supplier Engineer II – Clonmel Boston Scientific is seeking a highly motivated Supplier Engineer II on a permanent basis to join our team at our Clonmel site. Job Purpose As the Supplier Engineer P2 you will evaluate, select, and apply standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. The Supplier Engineering assignments have clear and specified objectives and require the investigation of a limited number of variables. You will act as liaison between materials and other groups in resolving problems encountered in the supply chain. Key Responsibilities Participates in large‑scale projects or leads smaller scale projects under guidance from senior engineering staff. Competent in the use of all relevant business tools including material qualification activities (AA/FA), SCIA, technical understanding, NCEP process, and all required PDM activity. Participates in project teams cooperating with cross‑functional team members to qualify and improve supplier processes. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project. Interfaces with suppliers with support from commodity team members to support investigation of supplied material issues or supply constraints. Execute NCEP/CAPA investigations to determine and address root cause for defective components at receiving inspection. Support NCEP/CAPA investigations where defects in supplied materials are identified elsewhere in production. Support product complaints. Education & Experience Level 8 Hons Bachelor degree in Engineering, Chemical or Material Science or Science is required. Minimum 2 years engineering experience. Excellent project management and communication skills. Previous experience in working with suppliers in medical device industry desired but not essential. Individual must be self‑motivated and results oriented. Equal Opportunity Statement Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com. #J-18808-Ljbffr
Boston Scientific is hiring a Process Engineer II for its Clonmel facility. The role involves mechanical engineering support in developing new medical device products. Responsibilities include researching and developing materials, maintaining documentation, and executing validation processes. Candidates should hold a Level 8 Hons Bachelor Degree in Engineering and have 3+ years of engineering experience in a GMP environment. The company values diversity and is an equal opportunity employer, providing accommodations for applicants with disabilities. #J-18808-Ljbffr
Boston Scientific is looking for an S/W QA Engineer in Galway, Ireland. In this role, you will develop, establish, and maintain quality engineering methodologies that meet regulatory requirements. Key responsibilities include ensuring compliance with software validation practices, providing guidance on Non-Device Software Lifecycle processes, and driving the culture of quality within the team. A Level 8 Hons Bachelor Degree in Software Engineering or a related field and a minimum of 3 years of relevant experience are essential for this role. #J-18808-Ljbffr
Process Engineer II Boston Scientific is seeking a Process Engineer II (P2) to join its Process Development Team at the Clonmel facility. The role will work cross‑functionally in the development of complex technologies on new products to ensure efficient and effective transfer of product into production. Purpose Responsible for providing mechanical engineering support in the creation and development of new medical device products (invasive and non-invasive). Interfaces with Design, Quality and Manufacturing organizations to integrate new products, equipment sets or processes into production. Responsibilities Researches, develops, designs, and evaluates mechanical and electro‑mechanical materials, components, assemblies, processes and/or equipment. Conducts feasibility studies to verify capability and functionality. Develops new concepts from initial design to market release. Maintains detailed documentation throughout all phases of development. Works as part of the Process Development group to aid design of new equipment for new products and manufacturing. Works closely with machine vendors to ensure that the equipment is designed, built & tested according to Boston Scientific specifications and is properly handed over to manufacturing. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. Executes the functional deliverables associated with the PDP/TDP and Quality Systems. Plans, organizes, and conducts all aspects of technical reviews. Ensures proper documentation is completed to meet quality systems requirements such as BOMs and FMEAs. Reviews or coordinates vendor activities to support development. Demonstrates knowledge and application of Lean methodologies and process improvement tools in identification and elimination of waste process steps and development of efficient, cost‑effective equipment and processes. Demonstrates knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), FMEA, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes. Co‑ordinates execution and documentation of validation builds, co‑ordinates testing of validation units and the compilation, analysis and reporting of the validation results. Demonstrates a primary commitment to patient safety and product quality. Understands and complies with all regulations governing the quality systems. Qualifications / Experience Level 8 Hons Bachelor Degree (or higher) in Engineering or relevant discipline. 3+ years engineering experience in a GMP environment. Experience in laser welding highly advantageous. Equal Opportunity & Reasonable Accommodations At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com . #J-18808-Ljbffr
Job Purpose As the S/W QA Engineer you will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide focused quality engineering support within new product development, operational, or system/services support. Key Responsibilities Ensures that Equipment & Software Qualification is carried out in compliance with Global & Site Policies, SOPs & WIs. Ensures that best software validation practices are employed by all departments so that Equipment & Software systems which have an impact on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established Regulatory, Quality System, and technical requirements. Provides guidance to teams on Non-Device Software Lifecycle processes at BSC including Equipment with Software, Software Only Systems, Spreadsheet Validation, Data Reporting Software, Artificial Intelligence Applications etc. Reviews and approves all deliverables associated with Equipment & Software Qualification Lifecycle to ensure Equipment & Software is qualified per its intended use (e.g. QP, PRA/EHA, EFS, EQP, SCS, EQR) including deliverables from other Software Qualification Lifecycles as applicable. Ensures that all new Equipment & Software, and updates to existing Equipment & Software systems are qualified according to established BSC Change Control processes. Ensures that all discrepancies and deviations encountered in Equipment & Software Qualification projects are adequately controlled, documented and addressed by the Project Team. Provides guidance and collaborates when required with project teams on associated documentation for equipment and systems. Provides software validation/compliance/part 11/ data integrity guidance in accordance with BSC policies and SOPs and industry and regulatory standards. Provides training to employees across various functions on Equipment & Software validation to ensure improved competency. Drives a culture of Right First Time to support patient and product safety while ensuring increased time efficiency and cost effectiveness for the business. Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Possess technical competency to drive improvement in the Software Quality department processes through automation. Supports department initiatives in driving Business Service Excellence and VIP initiatives. Education & Experience Level 8 Hons Bachelor Degree in Software Engineering, Quality or relevant discipline. Minimum 3 years experience in a similar role. Requires expanded conceptual and technical and/or functional knowledge in own job function. Broadens capabilities in applying concepts in job function. Requires technical and/or functional knowledge or the ability to learn for the following: Languages: C#, C++, Java, VB.Net, Python, etc. Database: SQL. Power Apps: Power BI, Power Automate, etc. Artificial Intelligence Applications. Compliance Requirements Working knowledge of business and industry practices and company processes to accomplish own work. Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions. Impacts quality of own work and the work of others on the team; works within guidelines and policies. Explains factual information of limited complexity to others in straightforward situations. Experience organising, presenting and explaining data/ information, primarily to internal audiences. Boston Scientific is a proud equal‑opportunity and affirmative action employer and is committed to providing reasonable accommodations for applicants and employees with a disability. If you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com. #J-18808-Ljbffr
Boston Scientific is looking for a Senior Process Development Engineer in Galway, Ireland. This role involves leading the development and validation of manufacturing processes for catheter-based medical devices, requiring strong expertise in electronics integration. Candidates should have over 7 years in process development within medical devices, along with a Level 8 Hons Bachelor Degree in a relevant field. The position offers an opportunity to mentor junior engineers and contribute to innovative medical solutions. #J-18808-Ljbffr
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Advancing possibilities for a brighter tomorrow Boston Scientific is seeking a highly motivated Senior Process Development Engineer on a permanent basis to join our team. Job Purpose The Senior Process Development Engineer will lead the development, characterisation, validation, and industrialisation of electronics‑enabled manufacturing processes for catheter‑based medical devices. This role requires strong electronics and PCB integration expertise, combined with demonstrated technical leadership and mentoring of engineers in a regulated medical device environment. Key Responsibilities Process Development & Electronics Integration Lead development and optimisation of electronics‑related manufacturing processes for catheter systems, including PCB, flex circuits, wire assemblies, sensors, and electrodes. Provide technical leadership on PCB and electronics integration into catheter assemblies, including DFM/DFA input to R&D. Partner with suppliers on PCB fabrication, electronics assembly, and component qualification. Validation, Quality & Compliance Own and execute Process Validation (IQ/OQ/PQ) and Test Method Validation activities. Author and approve PD documentation including PCs, PRAs, MVPs, MIs, and validation reports. Ensure compliance with ISO 13485, FDA QSR, and internal quality systems. Manufacturing Support & Continuous Improvement Act as escalation point for electronics‑related manufacturing issues, leading root cause investigations and corrective actions. Drive process robustness, yield improvement, and reliability enhancements. Technical Leadership & Mentoring Mentor and technically develop junior and mid‑level engineers within the Process Development organisation. Provide technical direction and coaching on electronics‑related process challenges. Lead or co‑lead PD workstreams, setting technical strategy and standards. Act as a subject matter expert (SME) for electronics processes within catheter programs. Education & Experience Level 8 Hons Bachelor Degree in Electronics Engineering, Electrical Engineering, Biomedical Engineering, or related discipline. 7+ years experience in Process Development / Manufacturing Engineering within medical devices or another regulated industry. Demonstrated hands‑on experience with electronics‑enabled medical devices, ideally catheter‑based systems. Direct experience with electrophysiology, diagnostic, or therapeutic catheters. Strong experience in PCB design and/or PCB integration (rigid and/or flex). Experience with flex circuits, embedded electronics, sensors, or high‑voltage signal systems. Supplier management experience for outsourced PCB or electronics manufacturing. Exposure to regulatory submissions, audits, or design reviews. Experience leading PD engineers or technicians in a formal role. Familiarity with statistical tools (DOE, Minitab, capability analysis). Experience supporting NPI through pilot and commercial launch. Proven experience leading process characterisation, validation (IQ/OQ/PQ), and risk management activities. Experience authoring and approving regulated technical documentation (PCs, PRAs, MIs, validation reports). Demonstrated mentoring or technical leadership experience (formal or informal). Strong structured problem‑solving and data‑driven decision‑making skills. Ability to work cross‑functionally with R&D, Quality, Manufacturing, and Suppliers. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem‑solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com #J-18808-Ljbffr
Boston Scientific is seeking a highly motivated Regulatory Affairs Specialist II to join their team in Clonmel. This role involves preparing and submitting regulatory applications, ensuring compliance with regulations, and providing guidance to cross-functional teams. A Bachelor's degree in life sciences or engineering is required, along with knowledge of FDA and international regulations. The company values diversity and is committed to an inclusive workplace, offering opportunities for career advancement. #J-18808-Ljbffr
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Advancing possibilities for a brighter tomorrow Boston Scientific is seeking a highly motivated Regulatory Affairs Specialist II on a permanent basis to join our team based at our Clonmel site. Job Purpose The Regulatory Affairs Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and ensures continued compliance with regulatory agency approvals. Key Responsibilities Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Review, assessment and sign-off on product and manufacturing changes in compliance with applicable regulations Provides technical guidance and regulatory training/mentoring to cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Develops and implements regulatory strategies for new and modified products. Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions. Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensures appropriate training is maintained to do the work and training is documented. Education & Experience Honours Bachelor's Degree (level 8) in life sciences, engineering or related field Basic knowledge of FDA and international regulations Ability to communicate complex ideas clearly and simply both orally and in writing Understanding of medical device regulations, FDA and international regulations. Team player with excellent interpersonal skills Demonstrated ability to effectively manage multiple projects and priorities General understanding of product development process and design control Ability to work independently with minimal supervision Submission drafting and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com #J-18808-Ljbffr
