Product Development Engineer – Medical Device Industry We are seeking a highly skilled and motivated Product Development Engineer to join a fast-paced and innovative medical device team. This role is central to the design, development, and optimization of next-generation medical technologies, involving both hardware and software components. You will work cross-functionally to bring products from concept through to commercialization, ensuring compliance with regulatory standards and a strong focus on patient outcomes. Responsibilities Include but are not Limited to: Lead product development activities from design and prototyping to testing, validation, and market launch. Collaborate with Operations, QA/RA, Technical Support, and Commercial teams to ensure smooth and compliant product development. Partner with Product Management to define product strategies and technical requirements aligned with business goals. Define design inputs, conduct feasibility studies, and contribute to the development of technical documentation including design history files and technical files. Work on embedded systems, firmware, and software development to support fully integrated device functionality. Conduct risk assessments and support the implementation of risk management strategies. Optimize designs for manufacturability, scalability, and performance. Manage the full product development lifecycle and ensure adherence to regulatory and quality requirements. Participate in design reviews and prototype evaluations, offering technical guidance across departments. Troubleshoot and resolve product issues during both development and post-market stages. Minimum Qualifications: Degree in Engineering (Biomedical, Mechanical, Electrical, or a related discipline). Minimum of 5 years' experience in product development, preferably in the medical device sector or a closely related field. Strong experience with embedded systems, firmware, and software development. Proven background in taking medical devices from concept to market launch. Solid understanding of design controls, validation, and regulatory compliance (e.g., FDA, ISO 13485). Proficient in both hardware and software product design, prototyping, and testing. Knowledge of mechanical engineering principles, manufacturing processes, and materials. Familiar with risk management techniques (e.g., FMEA) and regulatory documentation practices. Skilled in CAD tools (e.g., SolidWorks, AutoCAD), MATLAB, C/C++, Python, and embedded platforms. Core Competencies: Strong analytical, problem-solving, and decision-making skills. Excellent communication skills, both verbal and written. Proven ability to work cross-functionally with engineering, regulatory, quality, and commercial teams. Highly detail-oriented, proactive, and adaptable with a continuous improvement mindset. Preferred & Desirable Qualifications: Experience with auditory or wearable medical technologies. Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971 standards. Experience with PLM systems and product lifecycle documentation. Lean/Six Sigma or other continuous improvement methodologies. Ability to mentor and train junior team members. Track record of process and product optimization with risk mitigation. Flexibility to work in a dynamic and evolving environment. Willingness to travel internationally as required. #J-18808-Ljbffr
Social network you want to login/join with: Our Client a leading Life Sciences Organization is hiring an Analyst II for their Biopharma dept. The successful candidate will perform testing, review laboratory data, and advance proficiency in analytical techniques. This role involves gaining deeper insights into business processes, ensuring quality standards, and supporting continuous improvement initiatives. Responsibilities Include but are not Limited to: Becoming familiar with work practices and documentation requirements through formal training during the first six months. Gaining a deeper understanding of company processes, including customer awareness, lab safety, and operational efficiency. Acting on initiative to learn and master testing or data review tasks as required. Achieving proficiency in specific procedures and training modules as outlined in the training plan. Performing techniques/tests for which they are qualified according to completed training records and under the direction of senior laboratory staff. Training Analyst Level 1 and other Analyst Level 2 staff on techniques/tests they are proficient in. Developing a detailed understanding of the company’s quality systems, including managing deviations and calibration of basic-level equipment. Preparing or reviewing customer reports for approval by senior staff. Providing cover for other team members as required. Keeping training records up to date and proactively initiating training as per the training plan. Adhering to all company standards related to safety, housekeeping, and quality, and notifying management of any discrepancies. Ensuring full compliance with customer requirements and being flexible to work in any area of the business as needed. Identifying opportunities for improvement in quality and service and collaborating with the team to implement continuous improvement initiatives. Participating in the company On-Call/Call-Out rota as required. Education: A degree or diploma in Chemistry or a related discipline is required. Experience: At least 1 year of experience in a GMP laboratory. Skills and Competencies: Strong documentation skills with attention to accuracy and detail. Good communication skills both internally and externally, with the ability to understand and articulate customer needs. Passionate about quality and customer service. Good team player who is organized, dependable, and accurate. Ability to work effectively within a team and independently. High level of dependability, reliability, and integrity. Performance Competencies: Builds Customer Allegiance : Dedicated to meeting customer expectations, building long-term relationships, and ensuring deliverables are completed on time. Focus on Growth : Works towards business goals with a commitment to excellence and is willing to take responsible risks to achieve results. Job Knowledge : Comprehends all phases of work, utilizes relevant theories and practices, and understands related departmental functions. Teamwork and Cooperation: Adapts to change positively, promotes good attitudes, and maintains professionalism during conflicts. Interpersonal Skills: Builds positive working relationships, maintains confidentiality, and listens actively to ensure understanding. Dependability : Reliable in attendance and assignment completion, with initiative to assist during absences. Safety: Prioritizes workplace safety, attends safety meetings, and adheres to established safety policies. Personal Development: Proactively seeks learning opportunities and is receptive to feedback for continuous improvement. Problem Solving and Decision Making: Utilizes problem-solving tools before making decisions, proactively presents solutions, and seeks preventive measures. This role provides an opportunity to perform high-quality scientific analysis while contributing to continuous improvement, customer satisfaction, and team collaboration. Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies. -Pale Blue Dot Recruitment - The Resource for the MedTech Workforce- #J-18808-Ljbffr
Social network you want to login/join with: Our client is hiring a Senior Analyst for their Biopharma dept. to perform scientific test procedures on client samples, ensuring accurate and timely results. This role involves handling complex analysis, developing new testing methodologies, and maintaining the highest standards of quality and safety. Responsibilities Include but are not Limited to: Constantly being aware of customer requirements and striving to meet them, ensuring the cycle is complete when the customer receives their report. Performing non-routine tasks in the laboratory or specific types of analysis, including backfilling for Analysts as needed. Developing and validating new tests and procedures for the company and clients. Completing technological projects and documenting results accurately, confidentially, and on time. Signing technical documents (e.g., laboratory reports, SOPs, protocols) once qualified. Authorizing customer work from Analysts once qualified. Deputizing for supervisors/managers when required. Maintaining a clean and tidy laboratory area, including both visible and hidden spaces. Providing cover for other staff as needed, including participating in weekend rotas or overtime schedules. Ensuring all documentation is completed accurately, on time, and legibly. Keeping training records up to date and initiating training when necessary. Updating relevant documentation as required. Leading by example in safety, housekeeping, and quality standards, and notifying management of any discrepancies. Handling customer-related queries and collaborating with the team to resolve them. Being flexible to work in any area of the business as needed to meet customer requirements. Identifying opportunities for improvement in quality and service and collaborating with the team to implement continuous improvement initiatives. Education: A degree or diploma in Chemistry or a related discipline is desirable. Experience: At least 4+ years of experience in a GMP analytical laboratory. Extensive experience in testing finished products using HPLC, with preference for experience in high potency products. Technical Skills: In-depth technical knowledge of chromatographic instrumentation (e.g., HPLC, GC), UV/Vis, and preferably dissolution testing. Strong documentation skills with attention to accuracy and detail. Customer-centric mindset, consistently striving to meet and exceed customer expectations. Strong communication skills, both internally and externally, with the ability to understand and articulate customer needs. Proven ability to build long-term customer relationships by anticipating and meeting their needs. Passionate about quality, safety, and continuous improvement. Team-oriented, with flexibility to adapt to changing business needs. Leadership abilities, with the capability to mentor others and deputise for supervisors/managers. High level of dependability, reliability, and integrity. Additional Skills and Attributes: Excellent problem-solving and decision-making skills, with the ability to proactively present solutions. Commitment to personal and professional development, with a proactive approach to learning. Strong interpersonal skills, maintaining professional conduct and confidentiality at all times. Demonstrated ability to work effectively within a team and independently. This role provides an exciting opportunity to contribute to cutting-edge scientific analysis while driving continuous improvement, customer satisfaction, and team growth. 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
Social network you want to login/join with: Tooling & Equipment Design Engineer – Medical Devices, Tipperary col-narrow-left Location: Job Category: - EU work permit required: Yes col-narrow-right Job Reference: bh1dbsha Job Views: 2 Posted: 07.05.2025 Expiry Date: 21.06.2025 col-wide Job Description: Location: County Tipperary (On-site) Contract: 24-Month Fixed Term (with potential for extension) Our client, a well-established engineering firm, is seeking a Tooling & Equipment Design Engineer to support the development of custom tooling and mechanical systems for implantable medical devices. The role is based on-site at a world-class manufacturing facility in County Tipperary. This is a hands-on, technically challenging role ideal for an experienced mechanical engineer who enjoys precision design, collaboration, and seeing their work make a real-world impact. Responsibilities include but are not limited to: Design and develop mechanical tooling, fixtures, and assembly equipment to support advanced medical device manufacturing. Create detailed 3D models and engineering drawings using CAD (preferably SolidWorks). Collaborate with manufacturing, quality, and product development teams to ensure seamless integration of new equipment and processes. Participate in design reviews, technical problem-solving, and continuous improvement initiatives. Liaise with external vendors, suppliers, and equipment manufacturers to ensure quality and timely delivery of components. Support the validation and qualification of new equipment and processes as required. 3+ years of mechanical design experience, ideally in tooling, fixtures, or automation within a medical device or regulated manufacturing environment. Strong proficiency in CAD (SolidWorks preferred). Solid understanding of mechanical engineering principles, materials, and production techniques. Proven ability to deliver detailed and accurate mechanical designs within project timelines. Excellent problem-solving skills and attention to detail. Strong communication and teamwork skills. Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies. -Pale Blue Dot Recruitment, The Resource for the MedTech Workforce- #J-18808-Ljbffr
Social network you want to login/join with: col-narrow-left Location: Job Category: - EU work permit required: Yes col-narrow-right Job Reference: 4eoec924 Job Views: Posted: Expiry Date: 17.07.2025 col-wide Job Description: A fantastic opportunity has arisen for an experienced Toolmaker on a 12 month Contract to join a well-established and forward-thinking precision engineering company based in Cork. This full-time role will see you working within the Finishing and Quality Department, helping to build new products, support ongoing production, and contribute to the delivery of high-precision components across multiple sectors. Responsibilities Include but Are Not Limited to the Following: Spark erosion, grinding, and assembly of custom parts and fixtures Conduct machine and tool setup, including routine maintenance and reporting any issues to the Engineering Supervisor Interpret and work from technical drawings and specifications Collaborate with engineering teams to support quality, testing, and validation processes Ensure all work aligns with internal procedures and applicable quality standards Support continuous improvement initiatives within the department Maintain accurate records and contribute to team meetings and feedback loops Recognised qualification or trade background in Toolmaking , Mechanical Engineering , or related discipline Minimum 2 years’ experience in a toolmaking environment, ideally within precision engineering or medical devices Hands-on experience with manual turning and milling , grinding, and assembly techniques Proficient in interpreting engineering/CAD drawings and working to tight tolerances Strong understanding of measuring equipment (micrometres, verniers, height gauges, microscopes, etc.) Experience with equipment maintenance, validation processes, and tooling setup Comfortable working independently and as part of a collaborative, high-performing team Familiarity with software such as SolidWorks or CAD/CAM packages is an advantage Clear communicator with good organisational and time management skills A strong focus on precision, quality, and continuous improvement Why Apply? You’ll join a team that values craftsmanship, innovation, and teamwork. Enjoy a low-stress commute, a supportive work environment, and excellent career development potential in a modern, purpose-built facility. Note: By applying for this position, you may also be considered for future or similar vacancies with Pale Blue Dot Recruitment’s client network. -Pale Blue Dot Recruitment , The Resource for the MedTech Workforce - #J-18808-Ljbffr
Social network you want to login/join with: col-narrow-left Location: Limerick, Ireland Job Category: - EU work permit required: Yes col-narrow-right Job Reference: l6t4ppm9 Job Views: 2 Posted: 26.05.2025 Expiry Date: 10.07.2025 col-wide Job Description: Our client, a precision-focused medical device manufacturer based in Limerick, is seeking a Production Planner / Supervisor to join their growing team. This is a key role within the operations function, combining strategic production planning with hands-on supervision on the manufacturing floor. The successful candidate will bring strong experience in production scheduling, planning systems, and Lean manufacturing methodologies. They will play a pivotal role in ensuring the smooth flow of materials and resources, driving operational efficiency, and maintaining high levels of output and quality. This is an exciting opportunity for an ambitious and solutions-oriented professional to contribute to operational excellence within a high-performance MedTech environment. Our client fosters a collaborative and innovation-driven culture, with a strong focus on quality, integrity, and continuous improvement. This is a full-time, on-site position based in Limerick, offering excellent career growth opportunities and immediate interview availability for qualified candidates. Responsibilities include but are not limited to: Develop and maintain accurate production schedules in line with customer demand, capacity, and resource availability. Monitor and adjust production plans to respond to changing priorities, materials availability, or unforeseen issues. Lead daily production meetings and coordinate closely with cross-functional teams (Engineering, Quality, Supply Chain) to ensure alignment. Supervise production teams on the shop floor, providing clear direction, support, and performance feedback. Drive the implementation of Lean manufacturing principles and promote a culture of continuous improvement. Monitor and report on key production metrics (e.g., OTIF, downtime, scrap rates) to support decision-making and operational improvements. Ensure adherence to all health & safety regulations, quality standards, and production procedures. Identify and resolve production bottlenecks and inefficiencies. Assist in capacity planning and resource forecasting. Support training and development initiatives for production staff. Degree in Engineering, Manufacturing, Supply Chain, or a related discipline. Minimum 3 years’ experience in a Production Planner, Production Supervisor, or similar role within a regulated manufacturing environment (Medical Device, Pharma, or Aerospace preferred). Strong understanding of production planning tools, MRP/ERP systems, and scheduling best practices. Proven experience in implementing or supporting Lean Manufacturing and Continuous Improvement initiatives. Strong communication and organisational skills with the ability to lead and motivate teams. Excellent problem-solving skills and a hands-on approach to managing operational challenges. Familiarity with ISO 13485 and Good Manufacturing Practices (GMP) is a distinct advantage. Immediate interviews available for suitable candidates. Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other future vacancies. -Pale Blue Dot Recruitment , The Resource for the MedTech Workforce- #J-18808-Ljbffr
Other (Marketing / Logistics/ Procurement / Planning) Medical Device Product Specialist | Nationwide (Ireland) Are you a confident communicator with a passion for healthcare and innovation? A dynamic opportunity awaits for an ambitious individual to join a forward-thinking medical device organization as a Medical Device Product Specialist . If you're driven by results, eager to grow your career, and excited to work at the intersection of science, technology, and patient outcomes — this could be your next big move. The Ideal Candidate : All candidates must hold a third-level qualification (minimum: NFQ Level 8 – Honors Bachelor Degree) and ideally bring 3+ years of experience from one or more of the following areas: Healthcare (clinical, surgical, or healthcare-related background – an advantage, but not essential as training is provided) Business (B2B Sales, Marketing, Finance, Accounting, Commerce) Science (Microbiology, Biochemistry, Neuroscience, Mathematical Sciences, Biology, R&D) Our Client is looking for someone who: Is a self-starter with an entrepreneurial drive and a hunger to succeed. Has a natural flair for presenting, with the ability to communicate complex technical information in an engaging, relatable way. Approaches challenges with a solution-focused mindset and thrives under pressure. Enjoys building genuine relationships and sees value in long-term client trust. Is eager to continuously learn, grow, and evolve within a commercial healthcare setting. Responsibilities include but are not limited to: Setting and achieving territory business development goals and sales targets Promoting a portfolio of surgical devices and healthcare solutions to medical professionals Building and maintaining strong customer relationships based on credibility and trust Gathering and sharing market intelligence, including customer feedback, competitor activity, and emerging opportunities Representing the brand at meetings, product demonstrations, workshops, and industry events Collaborating with internal teams to ensure high levels of customer service and operational excellence Job requirements NFQ Level 8 Honours Bachelor Degree in a relevant discipline (Healthcare, Business, Engineering, or Science) Minimum 3 years of experience in a relevant industry Strong interpersonal, communication, and public speaking skills Proven ability to manage a territory and work autonomously Must be currently residing in Ireland Willingness to travel nationwide A long-term vision to develop within the healthcare sales and marketing field What’s on Offer: Competitive base salary with bonus structure; Company car, expenses, and pension contribution ; Comprehensive training and onboarding; Supportive team culture focused on innovation and continuous improvement; Opportunity to join a growing company and make a real impact in the medical device sector Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies. 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Overview A leading provider of bespoke automation solutions for the medical device manufacturing sector is seeking a strategic, hands-on Operations Manager to lead its Galway operations. This is a key leadership role focused on driving excellence across production, supply chain, and procurement functions in a dynamic, fast-paced environment. This is an exciting opportunity for an experienced professional to shape core operational processes within a company that values safety, innovation, collaboration, and continuous improvement. Why Join? Influence critical operational functions in a high-impact, high-growth industry. Be part of a passionate, innovative team driving automation solutions for advanced manufacturing. Join a company culture committed to quality, safety, and performance. Responsibilities Lead and manage day-to-day operations across assembly, supply chain, procurement, and purchasing functions. Provide clear direction, coaching, and performance feedback to cross-functional teams. Drive continuous improvement initiatives using Lean manufacturing tools and data-driven decision-making. Coordinate production planning, scheduling, and resource allocation to meet delivery and revenue targets. Establish and monitor key performance indicators (KPIs) for safety, quality, delivery, and cost (SQDC). Foster a strong safety culture and ensure compliance with all regulatory, quality, and operational standards. Act as the primary operations liaison for customer projects, ensuring timely and high-quality delivery. Collaborate with engineering and project management teams to support efficient execution of customer solutions. Analyze operational data, identify trends, and implement corrective actions to optimize performance. Job requirements 5–10 years’ experience in operations management within a manufacturing or automation environment. Minimum 3 years’ project management experience in a cross-functional setting. Background in medical device, aerospace, or automotive manufacturing is preferred. Experience with mechanical and/or electrical machine assembly is a strong advantage. Proficient in Microsoft Office tools; ability to read and interpret technical drawings. Strong leadership, communication, and team development skills. Proven ability to manage complex workflows and prioritise competing demands. Experience in operational planning, budgeting, and performance monitoring through KPIs. Practical knowledge of Lean Manufacturing principles and continuous improvement methodologies. Full-time, permanent position based in Galway. Competitive salary and benefits package offered. Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other suitable roles. Pale Blue Dot Recruitment – The Experts in STEM Workforce Solutions #J-18808-Ljbffr
Our client is a industry-leading sampling and analysis organization. Due to unprecedented growth, the Company is currently hiring for a Training Program Manager. Responsibilities include but are not limited to: Training Program Development and Delivery Design and manage the delivery of comprehensive training programs on laboratory techniques, quality assurance, regulatory compliance, and safety protocols. Develop customized training solutions to meet the unique needs of external clients, ensuring client satisfaction and retention. Assess training needs through surveys, focus groups, and feedback from employees and clients, adjusting programs as needed. Internal Training Oversee the training process for Analysts On Contract and Quality Assurance Professionals, from onboarding to placement on client sites. Manage and optimize the internal training process, ensuring content is up-to-date and opportunities for additional value-added training are identified. Implement efficiencies in training delivery through the use of technology and innovation. Client Training Solutions Lead cross-functional teams to scope, develop, and implement new training modules and laboratories for external clients and / or onsite facilities or on client sites. Collaborate with clients to understand their training requirements and develop tailored solutions. Act as the primary contact for client training needs, maintaining strong relationships and incorporating client feedback for continuous improvement. Participate in pitching training services to new clients and identifying opportunities with existing clients. Quality and Compliance Assurance Ensure all training programs comply with industry regulations (e.g., ISO, INAB, HPRA) and uphold the highest standards of lab practice and safety. Conduct audits of training materials and practices to ensure compliance and identify areas for improvement. Stay informed about industry developments and integrate new methods and technologies into training programs where applicable. Team Leadership and Development Manage and mentor a team of trainers, overseeing workload, conducting performance evaluations, and supporting career growth. Conduct ‘Train the Trainer’ sessions to enhance the skills of the training team and ensure consistent delivery of high-quality training programs. Foster a culture of continuous improvement, collaboration, and professional development within the training team. Training Administration and Reporting Maintain comprehensive training records, tracking certifications, attendance, and feedback. Generate reports on training activities, performance metrics, and client feedback to inform leadership decision-making. Manage the training budget, delivering cost-effective solutions without compromising quality. Job requirements Bachelor’s degree in Life Sciences or a related field, with at least 5 years of experience in a training role within the life sciences or laboratory services industry. Strong understanding of laboratory procedures, equipment, and industry regulations. Familiarity with ISO, OSHA, and FDA standards is preferred. Demonstrated experience in designing, delivering, and evaluating training programs for both in-house and client-facing audiences. Excellent verbal and written communication skills, with the ability to simplify complex technical concepts for diverse audiences. Proven team management experience, with the ability to mentor and develop talent while promoting a positive team culture. Proficient in training software (e.g., Learning Management Systems) and MS Office; experience with e-learning platforms is advantageous. Highly organized, detail-oriented, and capable of managing multiple tasks simultaneously. Strong problem-solving skills and the ability to use initiative to address challenges. Flexible and adaptable to changing circumstances, with a "can-do" approach in a fast-paced environment. Personable and professional, with strong interpersonal skills and the ability to build relationships. Commercial awareness and the ability to engage with clients in a support capacity 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
Social network you want to login/join with: A fantastic opportunity has arisen for an experienced CNC Programmer / Machinist to join a modern, precision engineering company in Co. Cork. This full-time role is ideal for a detail-focused professional with strong CNC programming skills, looking to work in a forward-thinking, high-quality manufacturing environment. Responsibilities Include but Are Not Limited to the Following: Programming and setting up 3-axis and 5-axis CNC machines Creating and optimizing CNC programs using CAD/CAM software (Hypermill) Machining of high-precision parts, tooling, and fixtures Interpreting and adapting design concepts, modifying existing assemblies as needed Conducting program reviews and documenting CNC operations Performing routine machine maintenance and reporting issues to the Engineering Manager Collaborating with engineering and production teams to ensure part quality and efficiency Supporting process improvements and contributing to continuous development initiatives Minimum 2 years’ recent experience in a CNC machining/programming environment Strong foundation in CNC machining principles, including multi-axis setups Proficiency with CAD/CAM programming, preferably using Hypermill Experience working with Fanuc, Hurco, or Doosan CNC machinery is an advantage Solid understanding of engineering drawings, tolerances, and precision standards Skilled in using measurement tools such as micrometres, height gauges, and verniers Ability to work independently and communicate effectively within a team Good time management, attention to detail, and a proactive approach to problem-solving Background in toolmaking or mechanical engineering is beneficial You’ll be part of a collaborative, quality-driven team in a purpose-built facility — where your skills will directly contribute to the manufacture of high-precision products across several industries. Note: By applying for this position, you may also be considered for future or similar vacancies with Pale Blue Dot Recruitment’s client network. #J-18808-Ljbffr
