Location Ballina Department Research & Development Summary Provides scientific, technical, and people leadership for technology development within a medical device research and development organization. Leads a multidisciplinary team of scientists and engineers to advance innovative materials, technologies, and applied research that support current and future product platforms. Partners cross‑functionally to translate emerging technologies into feasible, compliant, and scalable solutions aligned with business strategy, while fostering a high‑performing, collaborative, and safety‑focused R&D environment. Responsibilities Provide scientific and technical leadership in the development and application of advanced materials and technologies used in medical devices. Define, manage, and execute the technology development portfolio, from concept evaluation through proof‑of‑concept and transfer readiness. Lead applied research projects with robust planning, execution, documentation, and technical decision making. Partner with product development, engineering, operations, quality, and marketing to integrate technologies into viable product and platform solutions. Act as a subject matter expert, setting technical standards and ensuring scientific rigor in data generation and interpretation. Lead, develop, and mentor a multidisciplinary team, ensuring clear direction, engagement, and continuous development of technical capabilities. Establish and manage external research collaborations, suppliers, and academic or commercial partners. Ensure compliance with internal standards, regulatory expectations, and health and safety requirements. Develop and manage budgets for research and technology development programs, balancing innovation, risk, and financial stewardship. Set technical direction and priorities for technology development initiatives aligned with business strategy. Lead and evaluate scientific investigations, technology feasibility assessments, and development decisions. Direct and review generation of technical documentation, protocols, and reports. Make informed decisions that balance scientific opportunity, risk, manufacturability, and compliance. Coach and evaluate performance of scientific and engineering associates. Serve as a key technical interface across R&D and with external partners. Essential Functions of the Role Communicate effectively across internal teams and with external stakeholders. High‑level decision‑making and resource allocation. Ensuring adherence to regulatory standards (e.g., EU MDR, FDA). Leading or contributing to innovation workshops and ideation sessions. Education & Work Requirements Bachelor’s Degree with 8-12 years of related experience. Education & Work Preferences Honors Bachelor’s degree in an engineering or scientific discipline. 8–12 years of relevant industry experience, preferably within medical device or regulated environments. Minimum of 5 years of people leadership experience in research, development, or technology development roles. Proven experience leading applied research or technology development programs. Doctoral degree (PhD) in a relevant scientific or engineering discipline. Experience developing polymer materials, surface modifications, or coating technologies for medical devices. Experience managing external research collaborations or suppliers. Strong financial and budget management capabilities. Experience working in global, cross‑functional R&D organizations. Competencies Be Agile – Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles. Be Customer‑Centric – Considers the needs, experiences and feedback of customers in all we do. Be People‑Focused – Builds trust and collaborates with an inclusive and empathetic approach. Be Performance‑Driven – Operates with an ownership mindset, driving meaningful outcomes. Live The Schneiders’ Legacy, Our Noble Purpose – Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles. Equity, Diversity, and Inclusion Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr
A leading medical device company in Ballina is seeking a technology development leader responsible for advancing innovative materials and technologies. You'll manage teams of scientists and engineers while ensuring compliance with regulations and driving R&D initiatives. Applicants should have a Bachelor's degree and at least 8 years of experience, along with leadership capabilities in research and development. The role offers growth in a collaborative and safety-focused environment. #J-18808-Ljbffr
A leading medical device company in Ballina is looking for a Senior Supplier Quality Engineer to ensure that sourced materials consistently meet quality and compliance standards. This role involves managing supplier quality performance, leading audits, and applying statistical methods to prevent defects and enhance supplier capabilities. The ideal candidate should have a Bachelor’s degree in Engineering or Science and 5-8 years of experience in quality engineering within a regulated environment, alongside proficiency in statistical analysis, communication, and cross-functional collaboration. #J-18808-Ljbffr
Senior Supplier Quality Engineer (SSQE) Location: Ballina The Senior Supplier Quality Engineer (SSQE) ensures that sourced materials, components, and services consistently meet quality, compliance, and business requirements. The role leads supplier qualification and ongoing performance management; drives resolution of incoming material issues; strengthens inspection strategies and test methods; and serves as the primary quality interface with suppliers and internal stakeholders. Working cross‑functionally with Quality, Engineering, Manufacturing, Supply Chain, and Product Development, the SSQE applies statistical methods, risk‑based thinking, and problem‑solving tools to prevent defects, reduce cost of poor quality, and improve supplier capability. The position supports audits, change control, and continuous improvement to uphold an effective, compliant quality management system across the external supply base. Responsibilities Lead timely containment, investigation (e.g., 5 Why/Is‑Is Not), and corrective and preventive actions (CAPA) for supplier‑related nonconformances and incoming material issues. Own supplier quality performance management: define expectations, monitor KPIs (e.g., incoming defect rate, on‑time NC closure), and facilitate reviews with suppliers and internal stakeholders. Plan, execute, and/or lead supplier quality system and process audits; track findings to effective closure and verify sustained effectiveness. Support new supplier selection and qualification, including technical assessments, validation/first article activities, and approval of quality agreements and control plans. Partner with Incoming Inspection to optimize sampling plans, measurement methods, and documentation; implement risk‑based reduced inspection where justified. Maintain and improve incoming test methods and inspection equipment in collaboration with Metrology/Engineering; ensure calibration and capability are in place. Facilitate Material Review Board (MRB) processes; disposition nonconforming product in accordance with procedures and regulatory expectations. Collaborate with Engineering/Manufacturing on specification clarity, drawing change control, and supplier change notifications to protect form/fit/function and compliance. Contribute to cost‑of‑quality reduction through scrap/rework avoidance, yield improvement, and supplier‑driven continuous improvement initiatives. Provide guidance and training on statistical techniques, measurement system analysis (MSA), and problem‑solving tools to internal teams and suppliers. Perform computer‑based work for extended periods; move between office, laboratory, and manufacturing areas in accordance with safety and quality requirements. Lead/facilitate meetings, audits, and supplier visits; prepare and present clear, data‑driven updates and recommendations. Handle samples, inspection fixtures, and measurement equipment; follow safe lifting and ergonomics practices. Occasional domestic/international travel may be required to supplier and company sites. Essential Functions Of The Role Support audits and regulatory reporting as needed. Follow standard operating procedures and safety regulations. Education & Work Requirements Bachelor’s Degree with 5-8 years of related experience. Education & Work Preferences Bachelor’s degree in Engineering or Science (e.g., Mechanical, Materials, Manufacturing, Chemical, Quality) or equivalent practical experience. Significant experience in supplier quality and/or quality engineering within a regulated manufacturing environment (medical device or similar), including supplier auditing and incoming quality control. Working knowledge of quality management system requirements and regulations relevant to medical devices (e.g., FDA 21 CFR Part 820/QMSR, ISO 13485) and application of risk‑based approaches. Demonstrated proficiency with statistical methods (sampling, SPC), problem‑solving and root cause analysis, and technical documentation/technical writing. Strong communication and collaboration skills with the ability to influence suppliers and cross‑functional partners; effective organization and attention to detail. ASQ certifications (e.g., Certified Quality Engineer (CQE), Certified Quality Auditor (CQA)) or ISO 13485 Lead Auditor credential. Experience conducting supplier process audits and process capability studies (e.g., MSA, Gage R&R, Cp/Cpk, PPAP/FAI). Knowledge of GMP expectations and familiarity with ISO 14971 risk management for medical devices. Background with plastics processes (e.g., injection molding, film sealing) and/or other relevant manufacturing processes. Experience with ERP/SAP and proficiency with Microsoft Office; exposure to Lean/continuous improvement methods. EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr
A global healthcare product company is seeking a Lead Packaging Engineer in Ballina, Ireland. This role involves leading packaging projects for innovative medical devices, ensuring compliance with regulations, and mentoring team members. The ideal candidate has over 6 years of experience in packaging in the medical field and strong analytical skills. Join a company dedicated to making a positive impact on lives through medical innovations. #J-18808-Ljbffr
A healthcare products company is seeking a Senior Project Manager in Ballina. The role involves leading cross-functional teams in product development and commercialization, ensuring alignment with organizational strategy. Candidates should possess a Bachelor's degree and 8-10 years of experience in managing complex product development projects, preferably in medical devices. Strong project management skills and knowledge of regulatory environments are essential for success in this position. Competitive compensation and a rewarding workplace culture are offered. #J-18808-Ljbffr
A medical device company in Ballina is seeking a proactive Senior Quality Engineer for a 12-month contract. This role involves ensuring compliance with regulatory standards, managing risk assessments, and providing real-time QA support. Candidates should have a degree in Engineering or Life Sciences and a minimum of 5 years in quality assurance in regulated industries. The total rewards package includes competitive pay, health insurance, and wellness programs. #J-18808-Ljbffr
A leading healthcare product firm located in Ballina is looking for a Lead Facilities Engineer to manage the reliable operation and maintenance of facility infrastructure. The role requires a Bachelor's degree and 8-12 years of related experience, including expertise in facility systems within regulated environments. Responsibilities include overseeing critical utilities, coordinating projects, and ensuring compliance and safety. If you possess strong problem-solving skills and experience with CAD tools, this is an excellent opportunity to contribute to meaningful projects. #J-18808-Ljbffr
Bachelor’s degree required. We Make Life More Rewarding and Dignified Location : Ballina Department : Research & Development Summary This role leads cross-functional teams in the development and commercialization of new products within the New Product and Process Development (NPPD) process. The Senior Project Manager oversees project planning, execution, and delivery of integrated business cases while ensuring alignment with organizational strategy. The role builds strong relationships with senior leaders, drives a high‑performance culture, and mentors project managers. It is accountable for delivering high-quality, market‑aligned outcomes and supporting continuous improvement across the product development lifecycle. Responsibilities Lead cross-functional core teams through all phases of product development and commercialization. Develop integrated business and commercialization plans supporting global product launch strategies. Plan, schedule, and manage project activities to meet objectives and compliance requirements. Track and manage project budgets, schedules, and ROI targets. Build strong partnerships with functional leaders and key stakeholders. Promote a culture of innovation, accountability, and results. Provide strategic guidance, structured thinking, and clear delegation to project teams. Mentor and coach project managers, core team leaders, and team members. Drive process adherence, best‑practice project management, and continuous improvement initiatives. Facilitate effective decision making using sound judgment and scenario evaluation. Provide input to annual planning regarding resource needs for development initiatives. Essential Functions Of The Role Communicate effectively via email, phone, and virtual platforms. Education & Work Requirements Bachelor’s Degree with 8-12 years of related experience Education & Work Preferences Bachelor’s degree required. 8–10 years of experience managing complex product development projects, preferably in medical devices. Minimum 5 years leading projects or cross‑functional teams. Experience with product development, commercialization, and enterprise‑level process initiatives. Knowledge of regulatory environments, including 21 CFR, QSR 830, ISO 13485, and ISO 14971. Master’s degree (e.g., MS, MBA, Engineering) preferred. PMP certification preferred. Experience in risk management, quality systems, and enterprise‑wide process improvement. Experience in matrixed environments with multiple stakeholder groups. Competencies Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles. Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do. Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach. Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes. Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles. About Hollister Incorporated Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings. EOE Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Job Req ID: 35778 #J-18808-Ljbffr
Senior Quality Engineer – 12 month contract We Make Life More Rewarding and Dignified Location : Ballina Department : Quality Job Summary We are seeking a proactive and detail-oriented Quality Compliance Engineer to join our Quality Assurance team for a 12 month contract . This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO 13485:2016 and the fully implemented EU MDR . Your responsibilities will include completion of end-to-end validation lifecycle (IQ/OQ/PQ) , performing rigorous risk assessments (pFMEAs) , and supporting the change control process to maintain product integrity. In addition, you will be a primary Quality Liaison for the production floor, supporting and driving root cause investigations and ensuring that manufacturing processes are stable, compliant, and ready for regulatory inspection. Key Responsibilities Product and Process Validation: Develop, review, and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes to ensure high-degree assurance of product requirements. Risk Management: Lead and maintain risk management files, including pFMEAs ensuring that all potential failure modes are identified and mitigated. Production Quality Support: Provide real-time QA support to the operations team to address non-conformances, perform root cause analysis, and implement effective CAPAs (Corrective and Preventive Actions). Audit Readiness: Support internal and external audits by maintaining accurate documentation and ensuring all plant personnel follow cGMP requirements. Statistical Analysis: Apply statistical techniques and tools (e.g., Minitab) to analyze process data, identify trends, and support data-driven decision-making for process improvements. Other duties as assigned. Qualifications Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or Life Sciences. 5+ years of experience in quality assurance or Validation in the medical device or a similarly regulated industry. Solid understanding of ISO 13485, EU MDR, ISO 14971 and relevant medical device regulations. Strong analytical and problem-solving skills; experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Excellent written and verbal communication skills, especially in technical writing and documentation. Proficient in data analysis tools such as Excel, Minitab, Power BI or similar. Preferred Certified Quality Engineer (ASQ CQE) or similar professional certification. Certified Internal or Lead Auditor. Knowledge of EU MDR and international medical device regulations. Six Sigma or Lean Certification is a plus. Competencies Strong attention to detail and commitment to quality. Ability to manage multiple tasks and projects in a fast-paced environment. Collaborative mindset with ability to work effectively across departments. Self‑motivated with a continuous improvement mindset. Our Total Rewards package Includes competitive pay, paid time off programs, peer‑to‑peer recognition, health and life insurance, wellness programmes and generous retirement savings. The anticipated base salary range for this position is €49,900‑€78,414. The actual salary varies based on applicant’s education, experience, skills, abilities, and other legitimate business factors. If applicable: This position is also eligible to participate in the Hollister Bonus Plan. The Company’s Health And Wellness Benefits Include Health Insurance Life Assurance Employee Assistance Programme Wellness Events throughout the year Company Pension Plan Annual Leave 24 days per year pro‑rata. EOE Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr
