Our client, a leading Medical device startup, is hiring an Embedded Software Engineer to lead the development of device firmware across a portfolio of products. Responsibilities include but are not limited to the following: Working with Design, Quality, Marketing, and Clinical stakeholders to define and document firmware/software requirements. Collaborate with electronic hardware design colleagues to identify suitable electronic components to meet design requirements. Write, test, and refine firmware to meet design requirements. Demonstrate compliance with requirements through extensive design testing. Preparing and reviewing test protocols for design verification and compliance testing (e.g. IEC 60601 series, IEC 62304). Problem solving test failures or product issues in the field and providing software solutions to prevent these issues. Preparing design documentation to ensure compliance with relevant standards, such as IEC 62304. Lead automation of processes to help us bring state of the art products to patients by: Identifying areas of potential improvement through automation. Writing code to automate testing processes successfully. Leading software validations to ensure we can use data gathered from automated test cycles. Creating and managing a software development lifecycles process, compliant with IEC 62304 and ISO 13485. Work with front-end innovation team to create early stage device, service, and software application prototypes for solution demonstrations with key opinion leaders, patients, and customers. Completed at least 3 significant software/firmware design projects from the definition of requirements through to production release. 4+ years of electronics and firmware design experience in a medical device company. Prior experience of writing documentation to support your software/firmware design. Experience with software tools for static and dynamic analysis, memory management, code coverage, and techniques for analyzing software. Experience of completing software validations per IEC 62304 and its application to Software Development Life Cycle. Familiarity with communication protocols like UART, SPI, I2C. Experience working to general quality standards such as ISO 13485. A qualification in Software Engineering, Computer Science, Electronic Engineering, Mechatronic Engineering, or similar. Nice to Have: Experience working with wearable or home-use medical devices. Experience working with front-end software prototyping and design tools. Experience working with ARM microcontrollers. Experience working with RTOS (Real Time Operating Systems). #J-18808-Ljbffr
Social network you want to login/join with: Manufacturing & Continuous Improvement Lead, Limerick Location: Limerick, Ireland Job Category: - EU work permit required: Yes Job Reference: 6r7wevuc Job Views: 4 Posted: 06.03.2025 Expiry Date: 20.04.2025 Job Description: Our client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Lean Manufacturing & Continuous Improvement Lead to join their team. The ideal candidate will have a strong technical background in CNC machining and mechanical engineering, with a hands-on approach to problem-solving. This person will be responsible for driving cost reduction, efficiency improvements, and operational excellence while implementing Lean and Six Sigma methodologies. They will also play a key role in mentoring teams, optimising production workflows, and supporting leadership duties within the organisation. Responsibilities include but are not limited to: Lead Lean Manufacturing and Continuous Improvement (CI) initiatives across manufacturing operations. Identify and implement cost reduction strategies while improving production efficiency. Drive process optimisation and waste elimination through Lean and Six Sigma methodologies. Optimise CNC machining processes to improve performance, reliability, and cost-effectiveness. Develop and implement training programs for employees on Lean principles and best practices. Support and participate in Kaizen events and problem-solving activities. Assist in production scheduling to ensure optimal resource utilisation. Maintain and monitor KPIs to track and drive productivity improvements. Work closely with cross-functional teams, including engineering, production, and quality, to enhance overall manufacturing performance. Ensure compliance with health & safety and regulatory requirements. Provide hands-on support on the shop floor, assisting in daily manufacturing challenges. Drive process validation for new product introductions (VP, IQ, OQ, PQ) and manage associated documentation. Support cost management initiatives through data-driven analysis and decision-making. Perform all other duties as assigned. Minimum Requirements: Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field. Extensive knowledge and hands-on experience with CNC machining. Proven experience in Lean Manufacturing and Continuous Improvement. Strong leadership and training capabilities with the ability to mentor teams. Experience in cost reduction strategies, process validation, and waste minimization. Knowledge of Lean tools such as 5S, Value Stream Mapping (VSM), Kaizen, Kanban, and Root Cause Analysis. Experience working with ERP/MRP systems for scheduling and resource planning. Excellent problem-solving and analytical skills with a hands-on approach. Strong communication skills with both internal teams and external stakeholders. Ability to work cross-functionally in a fast-paced, results-driven environment. #J-18808-Ljbffr
Our client, a leading medical device company based in Roscommon, is hiring a Moulding Engineer to join their team. The Injection Moulding Engineer will work with the engineering and technician teams to develop new products and optimize moulding processes within the company. The Injection Moulding Engineer will lead the specification, introduction, validation, and continuous improvement of equipment and processes. The successful candidate will report to the Business Unit Engineering Manager. Responsibilities include but are not limited to: Perform root cause analysis reports as required. Troubleshoot production moulds and processes as issues arise. Coordinate PM activities of machines/tools and ancillary equipment. Generate associated moulding documentation such as SOPs, IQs/Protocols, DMRs, process travellers, and work instructions. Validate activities such as SIM (Scientific Injection Moulding) studies and other engineering studies for new processes and moulds. Execute DOE for new processes. Complete CPARs as required. Collaborate with customers, suppliers, vendors, and internal teams as required. Generate project timelines and ensure project milestones are achieved on time and within budget. Liaise with Toolmakers regarding projects, preventive maintenance, and spare parts programmes. Coordinate and analyze metrology measurements during product development phases. Lead decisions on mould design and steel adjustments to meet tight tolerances. Ensure PMs are performed on all tools. Coordinate ongoing training activities with technicians (Internal & External). Research and introduce new moulding technical concepts as appropriate (Robotics, pick & place, sprue pickers, process monitoring techniques, cavity pressure monitoring, EDART). Familiarize yourself with a variety of processes to allow you to work across several product lines. Conform to the requirements of the quality and environmental management systems. Complete additional projects and ad hoc duties as assigned. Requirements: Level 7/8 degree in an Engineering discipline is desirable. 4 years’ experience in an injection moulding environment is desirable. Preferably have worked in the medical, packaging, or technological industries with experience of process validations. Must be capable of coaching and mentoring others. Good data analysis capabilities and familiarity with statistical software (ideally Minitab). Knowledge of medical device validation protocols and associated documentation. Implementation experience of validation protocols. Lean and Six Sigma knowledge. Strong process engineering background. New product introduction experience. Strong team player with the ability to work collaboratively in a cross-functional team. Ability to plan, organize, and prioritize own daily work routine to meet established schedules. Excellent written and verbal communication skills. Strong proficiency in statistical analysis techniques to investigate and solve problems and improve quality. #J-18808-Ljbffr
Our client, a leading medical device company in Galway, is hiring a Quality Engineer to join their team. Responsibilities include but are not limited to: Performs routine assignments using existing procedures to solve standard problems. Works under close supervision and receives instruction, guidance, and direction from more senior level roles. Has no discretion to vary from established procedures by performing structured work assignments. Analyzes information and standard practices to make judgments. Exchanges straightforward information, asks questions, and checks for understanding. Job Requirements Degree/Diploma qualification in Engineering, Science, and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry. A minimum of 3 years experience in a similar role. Excellent attention to detail. Ability to use problem-solving tools (A3, PDCA, 5 Why’s, Fishbone, etc.). Good communication skills both verbal and written. A positive attitude in dealing with people. Experience working with Data Analysis Software (i.e. MiniTab) is an advantage. Understanding of lean principles; Lean green belt is an advantage. Ability to learn and adapt to various situations. #J-18808-Ljbffr
Our Client is seeking an experienced Microbiology Trainer to join their business and coordinate the development of Microbiology Analysts at their Medpharma Lab. Reporting to the Associate Director of Microbiology, this role is pivotal in designing and delivering robust training programs that prepare analysts to meet the technical, procedural, and professional expectations of our clients. The ideal candidate will have a strong background in microbiology, a passion for training, and the ability to foster a culture of quality and continuous improvement in a fast-paced environment. Responsibilities Include but Are Not Limited to the Following: Training Program Development: Develop and implement comprehensive training curricula covering microbiological testing techniques, lab protocols, and industry standards. Contribute to the creation of training materials, including manuals, SOPs, presentations, and hands-on practice guides. Conducting Training: Deliver theoretical and practical training sessions to analysts. Train analysts in pharmaceutical and medical device microbiology, including environmental monitoring, endotoxin analysis, bioburden, and water testing. Ensure trainees are proficient in GMP/GLP practices. Assessment and Certification: Evaluate trainee performance through practical assessments, exams, and observations. Provide constructive feedback and support to help trainees achieve proficiency. Certify analysts as ready for deployment to client sites. Supervision: Manage the day-to-day supervision of microbiology analysts before their placement with clients, including scheduling and resource management. Review documentation, data, investigation reports, and deviations to ensure compliance and accuracy. Provide coaching and feedback to analysts to build confidence and improve performance. Participate in weekly status meetings, reporting on trends and managing KPIs. Quality and Compliance: Ensure adherence to regulatory standards such as ISO 17025. Emphasize compliance with GMP practices and foster a culture of quality and safety. Promote continuous improvement in processes and practices. Collaboration with Stakeholders: Assist in the recruitment, interviewing, and onboarding of new analysts. Align training programs with client needs and maintain communication with client representatives. Provide ongoing support to analysts post-training to address challenges and support development. Stay informed of advancements in microbiology, regulatory updates, and best practices. Regularly revise training programs based on industry developments and client requirements. Minimum Qualifications: Bachelor of Science Level 8 degree or a related field. Approximately 3 years of experience in a microbiology laboratory setting with GMP experience. Prior experience in training, mentoring, or supervisory roles (preferred). Proficient in microbiological techniques and compliance with relevant standards. Familiarity with laboratory equipment and software commonly used in microbiology labs. Strong communication and interpersonal skills. Leadership and mentoring capabilities. Detail-oriented with excellent organizational skills. Willingness to travel occasionally to client sites. Our Client will offer a competitive salary package and opportunities for professional development and growth within a dynamic and rapidly expanding industry. #J-18808-Ljbffr
Our client, a leading medical device company in Galway, is hiring a Quality Assurance Technician. Responsibilities include but are not limited to the following: Provide day to day Quality Technician support to assigned area. Disposition product appropriately, following quality system requirements. Prepare and update documentation such as Work Instructions, Product Routings (CHR’s), Visual Standards etc. as required. Prepare Engineering Change Orders (ECO’s). Obtain the necessary approvals and where necessary implement on the document control system. Perform inspections on product (incoming, in-process and final) as required. This may arise due to product quality investigations, incoming inspection capacity etc. Perform First Article Inspections as required. Collect and prepare data related to assigned area (e.g. inspection results, yield data, production volumes etc). Raise Non-Conformance Reports and ensure associated product is segregated, oversee that NCR’s are closed out in a timely manner. Perform in-process quality audits / standard work audits as required. Follow up with Suppliers on Non-Conformances where applicable. Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others. Requirements: Thorough knowledge of Client products and processes. Must be able to make product disposition decisions. Certificate/Diploma qualification in Quality is an advantage. Excellent attention to detail. Good communication skills both verbal and written. Positive attitude in dealing with people. Ability to learn and adapt to various situations. #J-18808-Ljbffr
Our client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Additive Manufacturing Lead to join their team. The ideal candidate possesses both a high level of technical expertise and an innate passion to explore novel manufacturing processes. You will play a critical role in taking new customer projects in Additive manufacturing from development through to high volume production. Responsibilities include but are not limited to: Owner of L-PBF capabilities in the company. Lead Additive Manufacturing specific NPI projects. Maintain the area to minimum Health & Safety standards. Ensure machines are in working order through ongoing PM scheduling. Dictate the production schedule to ensure building times meet business requirements. Develop roadmap for higher volume production process flow. Process validation for new products and processes; VP, IQ, OQ, PQ and associated documentation. Participate in team meetings on timeline projects. Develop and provide training for manufacturing team members. Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner. All other duties as assigned. Minimum Requirements: Bachelor's degree in either Industrial or Mechanical Engineering. Engineering experience in medical devices. Experience with Laser-Powder Bed Fusion. Experience with Lean, Six Sigma, Kaizen, Kanban and 5S. Business understanding of operations and NPI. Strong communication skills with both internal and external agents. Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment. The individual should enjoy working in an aggressive, dynamic and results motivated team environment. Ability to effectively work cross-functionally with Product Dev., Quality, etc. #J-18808-Ljbffr
Our Client, a leading Manufacturing company in Sligo, is hiring a full-time Engineering Manager for their Manufacturing Facility. Reporting to the Plant Manager, this position is to lead a newly created Engineering Department incorporating new product and process development, process optimization/improvement, and environmental functions. The jobholder has the responsibility for investments in manufacturing machinery, tooling, and other production equipment based on the principle of "right-sizing" to achieve optimal flexibility for minimum investment and to reduce the risk of write-off losses due to changes in demand patterns and/or technology, while capitalizing on advantages available from new technologies. Responsibilities include but are not limited to the following: Act as Strategic Manager of multiple technologies to include all local site services (air, water, electricity). Development and implementation of necessary systems, procedures, and protocols ensuring adherence to Quality Management System and Design Control requirements. Compliance with all regulations relevant to the role regarding maintenance of effective Health and Safety, Environmental, and Quality systems. Development and implementation of a complete asset management system including maintenance functions. Identification and selection of best value technologies. Preparation of annual operational and capital expenditure budgets. Management of agreed budgets, hiring, day-to-day management, and project resourcing. Delivery of profitable on-time product/project launches. Prioritize and drive execution of multiple complex department projects; sponsor and support value improvement in the operation. Ensure efficient and timely transfer of process knowledge from project personnel to manufacturing engineers and coordinate the training of production team members on new processes and equipment. Establish and support a work environment of continuous improvement that aligns with our customer’s quality policy. Initiate cross-functional partnerships to identify and resolve production/engineering issues. Managerial, leadership, and employee development, ensuring adequate training is provided to satisfy all operational and health and safety requirements. Minimum Requirements: Degree in Engineering. 5+ years within a manufacturing environment at a senior level. Organized, highly motivated, enthusiastic, and energetic individual with a goal-focused attitude able to work effectively with other functional areas. Expertise in project management and resources management in a complex demanding environment gained from experience in high volume manufacturing. Technically astute, numerate, and possessing excellent analytical ability. A highly confident team player with a quality-focused approach and an innovative approach to problem-solving demonstrating a "Right first time" approach and attention to detail. Excellent interpersonal skills dealing with people and situations at all levels. Strong people management skills, written and verbal communication skills along with effective presentation skills. Knowledge of the latest plastic injection mould tool, metal stamping, and automation technology. A proven knowledge of technology deployment. Possess a good understanding and application of quality PSW/PPAP/APQP, lean principles. Measures effectiveness and has a strong business and financial acumen. #J-18808-Ljbffr
Social network you want to login/join with: Location: Waterford, Ireland EU work permit required: Yes Job Description: An exciting opportunity has arisen for a Validation Engineer (Metrology) to support operations by executing the metrology schedule and helpdesk activities in a fast-paced, GMP-regulated environment. This role will be a key point of contact for all metrology-related activities, including calibration, qualification, preventative maintenance, and compliance with regulatory standards. The successful candidate will ensure that all internal client requirements are met or exceeded while maintaining the highest standards of quality and productivity. Responsibilities Include but Are Not Limited to the Following: Perform calibration and qualification of equipment as per schedule, ensuring all documentation is accurate, timely, and compliant with GMP requirements. Manage the Metrology Helpdesk, generate reports, and track key performance metrics. Handle unscheduled calibration following repairs or equipment movement and maintain preventative maintenance records. Coordinate servicing and repairs, including liaising with vendors, arranging visits, and managing documentation post-repair. Maintain calibration, qualification, and preventative maintenance schedules. Review and approve external calibration certificates and generate internal certification records. Ensure all SOPs related to calibration and validation are up to date, periodically reviewed, and continuously improved. Support internal and external audits by providing documentation and assisting with compliance reviews. Monitor and address audit observations, change controls, CAPAs, and deviations. Adhere to all safety, housekeeping, and quality standards while maintaining a customer-centric approach to metrology operations. Education & Qualifications: Bachelor's degree in Life Sciences, Engineering, or a related field. At least 3 years of experience in a laboratory or GMP-regulated environment, preferably with calibration experience. Experience & Skills: Familiarity with pharmaceutical equipment calibration and validation processes. Strong understanding of GMP regulations and quality systems. Experience in documenting analytical data, writing reports, and maintaining compliance. Ability to work independently or as part of a team in a fast-paced environment. Strong communication and organizational skills with a quality-first mindset. Experience using preventative maintenance systems and metrology tools. Personal Attributes: Detail-oriented with a strong commitment to compliance and continuous improvement. Proactive problem solver with a structured approach to troubleshooting and decision-making. Strong ability to collaborate with internal stakeholders and external vendors. What's On Offer: Competitive salary package. Opportunities for career development and professional growth. A collaborative work environment with a focus on quality, innovation, and customer service . Exposure to a dynamic and regulated industry with global best practices. Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies. #J-18808-Ljbffr
Our Client, an exciting medical device start up in Galway City, is hiring a Quality Engineer. The successful candidate will support process quality and design assurance. The level of seniority can be tailored to the expertise of the suitable candidate. Collaborating closely with R&D, Clinical, Regulatory, and Manufacturing Engineering teams, you will provide essential quality expertise for our clients' products. Your role will also involve contributing to design considerations for manufacturing and assembly. Most importantly, you should enjoy working in a dynamic, fast-paced environment, be enthusiastic about engaging with people, and excel at taking ownership to deliver projects on time, ultimately making a meaningful impact on patients' lives. Responsibilities include but are not limited to the following: Ensure smooth transition of activities from design to manufacturing e.g. transition of dFMEA to pFMEA, transition of Design Specifications to Manufacturing Specifications, transition of Design Test Methods to Process Test Methods, etc. Support Design Verification and Design Validation testing and associated methods. Together with the R&D team, plan & support builds for R&D testing, product verification, clinical trials and commercial use of patient-facing medical devices. Lead the transfer of an assembly line for electromechanical medical device(s), with guidance from the Project Manager and Quality Director. Support validation of equipment and processes as required. Work with existing and future external manufacturing partners and suppliers. Continually look for opportunities to optimize processes. Minimum Requirements: Engineering, scientific or technical degree (including ASQ CQE). 3 years+ engineering experience working within an ISO 13485 QMS or equivalent environment. Experience in optimizing processes with a view to Design for Manufacturability (DFM). Installing and validating new equipment/processes/test methods. Problem solving & root cause investigations. Technical Skills: Use of statistical tools and proficiency in MS Excel & MS Word. Comfortable and confident communicating with internal and external stakeholders. The ideal candidate will be: Creative : Enthusiastic problem solver with innovative ideas. Open : Embraces and shapes company culture; gives and receives constructive feedback positively. Communicative : Strong written and verbal communication; clearly articulates ideas with supporting evidence. Self-Driven : Resourceful, independent, and proactive; prioritizes personal development. Organized : Effectively prioritizes tasks and ensures timely completion. Team-Oriented : Thrives in multidisciplinary collaboration towards shared goals. Experience Advantages: Lead Auditor Certification. Experience in manufacturing, PCB/electromechanical components, or process validation. Background in startups/SMEs, line transfers, or training others. This key early role at a fast-growing company offers the chance to shape impactful patient-facing products and gain insights into novel technology development. Our Client will provide a competitive salary, flexible benefits, comprehensive training, and opportunities for personal growth. You will enjoy flexible working hours, generous vacation allowances, and a focus on work-life balance. #J-18808-Ljbffr
