Boston Scientific Gruppe in Galway, Ireland, is seeking a highly motivated Senior Process Development Engineer. This role involves leading the development of electronics-enabled manufacturing processes for catheter-based medical devices. Candidates should possess a Level 8 Hons Bachelor Degree in Electronics Engineering or related fields along with 7+ years of experience in process development. The position offers the opportunity to mentor junior engineers and ensure compliance with quality standards including ISO 13485. #J-18808-Ljbffr
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. 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). Ability to work cross‑functionally with R&D, Quality, Manufacturing, and suppliers. 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 Gruppe is looking for a highly motivated Regulatory Affairs Specialist II for their Clonmel site in Ireland. The role involves managing regulatory approvals, providing guidance to teams, and ensuring compliance with FDA and international regulations. Ideal candidates will have a Honours Bachelor’s Degree in life sciences or engineering, strong project management, and interpersonal skills. This position offers a dynamic environment focused on advancing medical solutions and improving patient health. #J-18808-Ljbffr
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 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 Job Segment Regulatory Affairs, Compliance, Drafting, Testing, Law, Legal, Engineering, Technology #J-18808-Ljbffr
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 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 Job Segment Regulatory Affairs, Compliance, Drafting, Testing, Law, Legal, Engineering, Technology #J-18808-Ljbffr
Boston Scientific Gruppe is seeking a highly motivated Regulatory Affairs Specialist II to join our team at the Clonmel site. This permanent position involves handling regulatory approvals for medical devices, ensuring compliance with FDA and international regulations, and providing guidance to cross-functional teams. Ideal candidates will possess an honours bachelor's degree in life sciences or engineering, strong communication skills, and experience with multiple software applications. We value diversity and encourage problem-solvers to apply. #J-18808-Ljbffr
A leading medical technology company in Edenderry is seeking a Product Builder to work in a clean room environment. This role offers excellent career opportunities with a focus on high-quality assembly of medical devices. The successful candidate will have a Leaving Certificate or equivalent and be part of a motivated team. The position is a fixed-term contract for 11 months, offering competitive compensation and various employee perks, including bonuses and healthcare. #J-18808-Ljbffr
Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert 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. Our Product Builders work at the heart of operations in Clonmel building the products that help to change lives.Excellent career opportunities for motivated individuals who are excited to work for one of Irelands largest medical device companies. Our total rewards package offering includes a competitive salary, shift allowance, paid vacation, bonuses, healthcare, defined pension scheme, further education assistance, excellent career progression opportunities, Employee Resource Groups, retirement programs, wellness programs, greenway, gym on site, subsidised canteen, on-siteparking, as well as other various social activities. We are offering an 11-month fixed term contractto work on various shift patterns which include Day/Evening across its manufacturing lines. The Role willwork well within a small team and perform a wide variety of electronic, mechanical, or electro-mechanical assembly operations on assemblies or sub-assemblies in a clean room environment.The Product Builder will be responsible for set up and operation of automatic or semi-automatic machines and may also perform other tasks including, but not limited to, placing labels on packages and putting data sheets with product. The key responsibilities for this role include: Responsible for manufacturing consistently high-qualityproduct in accordance with Boston Scientific manufacturing procedures and quality standards. Monitor and verify quality in accordance with operating procedures. Fully adhere to procedures in relation to production methods, completion of documentation, current Good Manufacturing Practices and safety requirements. Proactively promotes safety across the site. Participate in continuous improvement programmes and / or team projects to enhance our quality, customer service and cost. Contribute as part of a team in achieving and exceeding the line core metrics. Undertake training in line with business needs in order to continually develop skills and knowledge to meet the demands of the business now and in the future. Provide cross training to employees. Continuously drive and promote our core values and behaviours. Required Qualifications Leaving Certificate with passed subjects to Include English and Mathsor equivalent required (HETAC Level 5) . Leaving Cert applied is equal to level 4 and does not meet criteria Desired Experience and Skills Previous work experience in Medical Device or Pharmaceutical environments is desirable. Strong aptitude for operating equipment in a GMP environment. Have the ability to work as part of a team and demonstrate a strong motivation towards teamwork. Must have demonstrated computer literacy. Excellent attention to detail. Must be flexible, highly motivated and committed with the ability to deliver results by taking the initiative and taking pride in consistently delivering high quality work on time. Be a self-starter, a quick learner and have a positive and enthusiastic attitude whilst driving our continuous improvement culture. As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen. Requisition ID: 616113 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 (NYSE: BSX) 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! Job Segment: Pharmaceutical, Medical Device, Medical Technology, Science, Healthcare #J-18808-Ljbffr
Boston Scientific Gruppe is seeking a Process Technician in Clonmel on a permanent basis. This role involves supporting the manufacture of high-precision components with a focus on mould set-up and maintenance using FANUC and Engel machines. Candidates should have NFQ Level 7 qualification in molding, at least 3 years of relevant experience, and strong communication skills. The position provides an opportunity to work in a collaborative environment, ensuring quality and compliance in manufacturing processes. #J-18808-Ljbffr
We are seeking a Process Technician S3 on a permanent basis to join our team at our Clonmel site. The shift for this position is 2-cycle shift Days & Evenings. Job Purpose: We are recruiting an Injection Moulding Technician to support the manufacture of high-precision components using FANUC and Engel machines. This will include mould set‑up, processing, maintenance of moulds and peripheral equipment. You will set up, run, and troubleshoot processes across both thermoplastic polymer and silicone materials, ensuring output meets strict quality and regulatory requirements. Key Responsibilities: Set up, operate, and monitor FANUC and Engel machines for the moulding of components. Perform safe and efficient start‑ups, shutdowns, purging, and product changeovers (moulds, material swaps, parameter resets, line clearance). Adjust and control key process settings (e.g., temperatures, pressures, speeds, clamp/shot settings where applicable, vacuum/cooling, cure/heat profiles). Maintain dimensional and visual quality through in‑process inspections using calibrated gauges and inspection standards. Diagnose and resolve equipment/process issues (alarms, yield, dimensional conformity, voids & defects). Complete batch records, traceability documentation, and equipment logs accurately and on time. Work closely with Quality/Engineering on nonconformance investigations, NCEP, CAPA, process trials, and validation support (IQ/OQ/PQ). General maintenance, calibration and troubleshooting of equipment, e.g., moulding machines, moulds, dryers and chillers, recording of all work orders in plant CMMS. Work in compliance with the site Safe Systems of Work including permitting, LOTO, isolations and safety documentation review. Work collaboratively with Operations, Quality, EHS and other departments. Perform any other reasonable duties which may be required by management from time to time. Requirements: NFQ Level 7 in moulding or relevant discipline. Moulding experience is required for this position. 3+ years of relevant work experience, ideally within Medical Devices or a similar industry. Ability to read electrical, mechanical, hydraulic & pneumatic drawings would be an advantage. Experience of working on & maintaining electrical and mechanical equipment within a regulated industry. Experience with SAP‑based Computerised Maintenance Management System and electronic Maintenance Request Systems. Excellent interpersonal and communication skills. Strong planning and organisational ability. Boston Scientific is an equal‑opportunity, affirmative action employer. We are committed to providing reasonable accommodations for applicants and employees with a disability. If you require a reasonable accommodation during the recruitment process, please email emailTalentAcquisitionIre@bsci.com . #J-18808-Ljbffr
