A leading medical technology company based in Ireland seeks a Senior Quality Engineer to oversee quality assurance processes. The role involves providing engineering support for capital equipment repair operations and ensuring compliance with medical regulations. Applicants should possess a Level 8 honours degree and have over 5 years of experience in regulated environments. This position is ideal for self-starters who can work independently while effectively collaborating within a team. The company promotes a diverse workplace and is committed to equal opportunity. #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 Purpose Demonstrates a primary commitment to patient safety and product quality. Understands and complies with all the regulations governing the quality systems. Provides expert support to Capital Equipment Repair Team as required helping to ensure delivery of highest quality product. Provides Process/Quality Engineering to support new product introduction to the site, helping to ensure development of highest quality new products. Key Responsibilities Become a Subject Matter Expert for quality related queries in the Capital Equipment Repair Operations area Interacts cross functionally and with Internal and External Customers. Serves as the Clonmel point of contact for the BSC sites in Arden Hills, Penang and Kerkrade for quality process related discussions / issues Leads the resolution of Quality Related issues for the area by leading / participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex corrections / corrective actions & documenting release criteria. Provides Quality Engineering support to ongoing Capital Equipment Repair Operations initiatives including product transfer projects and process alignment with sister sites Provides Quality System & External Audit support for Capital Equipment Repair Operations. Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Responsible for external audit preparation activities for the area. Leads/supports process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance and sustain Quality Metric performance in the area Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials. Coaches more junior members of the team through a wide range of tasks from line support to project support Requirements Level 8 honours bachelor's degree within a relevant field. 5+ years’of experience working within a highly regulated environment. Medical Devices experienceis desirable. Must have a strong vision and an ability to influence the organization in the direction of Quality & Compliance. The successful candidate must be a self-starter with the ability to work on own initiative, while possessing strong team player characteristics. 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 Senior Quality Engineer, Quality Engineer, Medical Device, Business Process, Engineering, Healthcare, Management, Quality #J-18808-Ljbffr
A leading medical technology company is seeking a Process Development Manager in Clonmel, Ireland. In this role, you will manage multiple process development projects and lead a designated professional team. Responsibilities include overseeing execution of functional deliverables, working with engineering teams, and ensuring compliance with company policies. Candidates should have a Bachelor's in engineering and 5-7 years of relevant leadership experience. #J-18808-Ljbffr
Process Development Manager of multiple process development projects or core technologies primarily supporting the Active Implantable Systems (AIS) Process Development team. The person is responsible for managing, leading and developing a designated professional team. Responsibilities Effectively manages multiple process development projects or core technologies by managing PD team and/or being a core team member for the Active Implantable Systems (AIS) Process Development team Defines goals and manages execution of functional deliverables associated with the PDP/TDP projects: examples include, PFMEA, capability analysis, DOE, root cause analysis, scrap analysis, Design Capability Matrix, COGS etc. Works with other engineering managers, core team members and core team leader to resolve technical issues and meet PIB goals. Coordinates all activities related to development by working with relevant functional groups in operations and R&D. Prioritizes and manages execution of multiple department projects. Works with the six-sigma engineers and lean coordinators to ensure flawless introduction of new products. Responsible for managing performance of direct reports, project staffing, PIB deliverables and launch deliverables. Management Requirements Lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Qualification and Experience Bachelor’s in engineering or related field. Minimum 5-7 years demonstrated People and Technical Leadership within a comparable new product development environment. Closing date: 4th January 2025 Requisition ID: 620425 Job Segment: R&D Engineer, R&D, Lean Six Sigma, Six Sigma, Compliance, Engineering, Research, Management, Legal #J-18808-Ljbffr
A leading medical technology company in Galway seeks a Senior Validation Engineer to lead daily validation activities. You will manage a team of validation engineers and ensure compliance with global standards and regulations. The ideal candidate has over 6 years of experience in the medical device industry, strong project management skills, and a Level 8 Bachelor's degree in engineering. Strong analytical and problem-solving skills are essential. This role supports a collaborative, fast-paced team environment. #J-18808-Ljbffr
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. Advancing possibilities for a brighter tomorrow Boston Scientific is seeking a highly motivated Senior Validation Engineer on a permanent basis to join our team. Job Purpose: Seeking a Senior Validation Engineer within the Global Equipment Engineering function to lead and manage day to day Validation activities across Galway and other sites as required. This role combines strong leadership and project management skills along with technical expertise in equipment and software validation. The ideal candidate will possess excellent analytical, system analysis and problem-solving skills, excel at guiding teams, driving complex projects to completion and thrives in a fast paced, collaborative team environment. Core Leadership & Project Management Responsibilities: Manage and mentor a team of validation engineers (staff & contractor), providing guidance, training, and career development support. Motivate and inspire individuals to achieve results while building a high-performing, engaged team culture. Provide project management, validation oversight and direction through all phases of the project lifecycle. Ensure validation deliverables meet project timelines, budgets, and scope, addressing changes proactively. Ability to assess schedule deviations and assist in the development of alternative methods for corrective action at the project level. Develop and enhance cross-functional team relationships and work collaboratively to identify and resolve issues. Key Technical Responsibilities: Ensure equipment and software validations comply with global and site standards, and applicable regulatory requirements, while maintaining up-to-date validation procedures. Ensure best validation practices are employed by the Equipment Engineering Group to maximise effectiveness and minimise non-value-add work. Works closely with customers to understand requirements and propose creative, cost-effective validation solutions. Partner with global engineering teams to share best practises and align validation strategies Travels to various BSC sites to Coordinate and oversee validation activities across multiple BSC sites as needed. Champions continuous improvement initiatives in validation processes, leveraging data-driven insights to enhance efficiencies. Education & Experience: Level 8 Bachelor’s Degree (240 credits) in a relevant engineering discipline with a minimum of 6+ years’ experience in a medical device industry. 6+ years’ experience in Validation Engineering, including protocol development & execution. Experience leading and developing teams, acting as a role model, and giving clear guidance and support. Demonstrated ability to manage groups with different skill levels effectively. Advanced knowledge of software validation Lifecycle Qualification & Risk based qualification strategies Proven ability to qualify and validate highly complex PC and PLC based automated systems Experience with Databases & multi-technology platform integrations is an advantage Strong project management/project lead experience with excellent interpersonal skills, PMP qualification is a distinct advantage. 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: Medical Device Engineer, Developer, Project Manager, Systems Analyst, Engineer, Engineering, Technology #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. Purpose Act as a member of the Boston Scientific Cork facility Quality Team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant. Defined Term - 18 months Key Responsibilities Supervision of Quality Technicians. Drive and implement process improvements to ensure predictable processes across all product lines (e.g., Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities). Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output. Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed (e.g., Use of DOE studies, FMEAs). Drive and implement plant-wide quality system improvements. Ensure Regulatory compliance in area of responsibility to cGMPs of all medical device regulatory agencies (e.g., FDA and TUV). Provide functional expertise to other support functions on quality related issues (e.g., regulatory requirements, statistical techniques, sampling principles). Identification and implementation of appropriate statistical techniques to monitor process performance (e.g., SPC, CpK analysis, sampling techniques). Approval of change requests for product, process and quality system changes. Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends. Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval. Compilation of required Regulatory documentation (e.g., Technical files, Design Dossiers, Product transfer files, Essential requirements). MRB: Review of MRB trends and identification of appropriate corrective actions when required. Perform internal quality audits. Support the implementation of Lean Manufacturing across the site. Transfer and implement product and processes from development or from another manufacturing facility. Education & Experience Minimum of Bachelor of Science Degree in Engineering/Technology. 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience in the medical device industry is an advantage. Experience on an automated/high volume line an advantage. Requisition ID: 603085 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! #J-18808-Ljbffr
A leading medical device company in Cork is seeking a Quality Assurance professional to provide expert QA support within the Quality Team. You'll be responsible for supervising technicians, driving process improvements, ensuring compliance with regulatory standards, and conducting internal audits. The ideal candidate holds a Bachelor’s degree in Engineering/Technology with 2-3 years of relevant experience in a manufacturing or QA environment. This is a defined term position for 18 months. #J-18808-Ljbffr
A leading medical device company in Cork is seeking a Senior Finance Analyst. You will partner with the Senior Finance Manager to secure financial incentives including grant aid and R&D tax credits. The ideal candidate has 5+ years of experience in financial analysis and strong skills in stakeholder management. This role offers the opportunity to advance your skills in a dynamic environment and contribute to meaningful health industry solutions. #J-18808-Ljbffr
A leading global medical solutions provider in Galway seeks a highly motivated Quality Engineer II. This role involves ensuring compliance with quality practices, engaging in problem-solving, and driving improvements in quality and processes. The ideal candidate will have a Level 8 degree in a relevant field and at least 3-4 years of engineering experience in a regulated environment, preferably medical devices. Join us in advancing science for life through innovative solutions. #J-18808-Ljbffr
