JOB TITLE: NPI Quality Engineer (12 Month FTC) DEPARTMENT:Quality Department REPORTING TO: Quality Engineering Manager About Sanmina Fermoy Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoys core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce. We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few. OBJECTIVES OF POSITION: Primary objective is to introduce any New Customer product effectively ensuring all requirements of Customer and IPC standard for PCBA assembly is achieved. Principal customer interface for NPI Quality, responsible for ensuring all procedures are adhered to and that all aspects of New product Introduction are documented and recorded effectively and that opportunities for product and process improvement are captured in the set up phase by reviewing and providing constructive feedback to the internal and external Customer teams. Overall objective is to provide a stable procedure based template to drive effective New Product Introduction ensuring component to PCB footprint design is evaluated effectively and that required validation activity including process FMEA, Control plan and Quality Plan for Customer cover all the necessary requirements. RESPONSIBILITIES: Management of all Quality requirements and approvals required to achieve first time approval of NPI introduction based on Customer requirements. Generation of standard NPI Quality template to drive robust approach to all NPI activity. Overall responsibility for generating comprehensive Quality plan and associated DHR appendix covering all Customer requirements as per any applicable Quality agreement. Overall responsibility for generating comprehensive team compiled Control plan and FMEA including process challenges and validation requirements prior to IQ/OQ/PQ phase. Data collection, analyzing and reporting of all NPI activity including standard template to document all NPI issues and concerns.. Pareto and trend analysis of all NPI activity. Initiate and drive Continuous Improvement programs based on NPI / Engineering prototype builds from Surface Mount assembly to any associated Post SMT Surface Mount Assembly requirements.. NPI Approval including First Article Inspections and Reporting. QSR Validation protocols and report (IQ, OQ & PQ). Effective step by step release and Quality checks of all New Product introduction phases covering risks in supply chain, component and material selection and fit for purpose suitability. Implement a detailed step by step Standard operating procedure that effectively covers all aspects of effective New Product introduction. Make NPI process more objective based with emphasis on minimum requirements for base line NPI process effectiveness utilizing SOP mentality and evidence based checks for all steps required in NPI process. Introduce objective Transfer to Manufacturing approval process ensuring each NPI is released to normal production with all aspects of the process defined and working to the required set out in Process Qualification phase. Quality: Assure ongoing compliance with quality and industry regulatory requirements Health & Safety: Ensure compliance with Health & Safety Legislation and Regulations. MEASUREMENTS: Yields at Key Process Steps for all NPI activity Customer Return % and Cost (RMA) Scrap % Outgoing Inspection DPM & Customer Incoming Quality Levels NPI success rate and post shipment trending NPI reports covering effective and detailed action list identifying area for improvement / owners of actions and definitive follow up and closure of open actions prior to any follow on manufacturing. PERSONNEL SPECIFICATIONS: ESSENTIAL: Degree / Diploma in Science or Engineering, or a lesser qualification with 5-10 years sufficient job related experience in a PCBA printed Circuit board assembly environment. Must have in depth knowledge of Surface Mount Technology assembly lines and associated Post SMT process control such as In Circuit Test, Flying Probe, Functional Test, Quality sampling and Batch release control. At least 2-3 years Quality Assurance / Regulatory affairs experience, in a similar Quality Engineering role in the electronics manufacturing industry. Sound understanding and utilization of Problem Solving Techniques Must have indepth understanding of IPC-A-610 manufacturing of printed circuit board assembly standard and clearly understand requirements of the standard. Proficient in the use of Microsoft Word, Power-point and Excel. Good Communications and strong influencing skills as well as ability to define New Product Introduction Quality controls from Purchasing controls to final shipment controls must have in-depth knowledge of entire process required to introduce new products. Ability to respond to common inquiries or complaints from internal customers and regulatory agencies. Ability to write standard operating procedures, training documents, and regulatory responses. DESIRABLE: Experience in working within a Class 3 Medical Device Manufacturing Environment. Six sigma Green or Black Belt Certified Knowledge of PCB Printed circuit board design requirements versus IPC standard. Experience of working with Fuji Surface Mount equipment such as solder paste inspection, NXT placement machines, Reflow oven criticality, Automated Optical inspection and general Statistical process control as well as familiarity with product testing such as In Circuit test, Functional test platforms.
JOB TITLE: Director / Head of Engineering DEPARTMENT: Engineering REPORTING TO: Vice President of Operations / Plant Manager OBJECTIVES OF POSITION Lead and scale a high-performing department of over 100 technical professionals across Facilities, NPI, and Advanced Manufacturing Engineering (Automation, Maintenance, Test, MES, and Product) to support existing production and future plant expansions. Act as a core member of the Senior Leadership Team (SLT) to define and implement the plant’s overall business strategy. Drive the end-to‑end planning, installation, and validation of automated manufacturing solutions, utilizing World Class Manufacturing (WCM) and Lean Six Sigma methodologies to support business objectives. Develop departmental technical capabilities and roadmaps in line with Sanmina and customer requirements. Drive cross functional programs in support of continuous improvements in quality, delivery and cost. RESPONSIBILITIES Direct end-to‑end process development for manufacturing, test, and automation, ensuring high yield, scalability, and compliance Identify and evaluate emerging technologies and trends in manufacturing and engineering to enhance competitiveness and stay ahead of industry developments. Lead the facilities & utility Management including maintenance and support of all site utilities, Building Management Systems (BMS), and janitorial services to ensure a safe and environmentally responsible facility. CAPEX & Project Leadership for all Capital Expenditure (CAPEX) projects from scoping and business case justification through to installation and validation. Ensure ongoing compliance and engineering standards for high volume manufacturing of medical devices in ISO8 cleanrooms. Foster a high‑performance culture through coaching, mentoring, career planning, and regular performance reviews to maximize individual potential Identify/sponsor or lead continuous improvement and cost reduction projects to support manufacturing of existing products. Provide both Process and Customer Support in technical, quality and commercial areas. Lead, facilitate, coordinate, and track activities required to ensure new products are completed on time, successfully, and in a manner consistent with organizational goals, plant policies, established processes, and/or the standard terms and conditions of the customer contract. Establish partnerships with key external stakeholders such as equipment suppliers and specialist material suppliers. Support customer’s visits and work with Business Development and Corporate Design teams to grow customer base. Ensure all new and existing processes are designed to comply with industry standards and H&S regulations. Support, participate & lead internal and external audit QUALITY Assure ongoing compliance with quality and industry regulatory requirements. HEALTH & SAFETY Ensure compliance with Health & Safety Legislation and Regulations. MEASUREMENTS Machine / process Uptime. Process Yield. Development of procedures and process. Completion of tasks / projects against set objectives in performance reviews. Completion of identified training programmes & development of department personnel. On‑time delivery of customer expectations for NPI builds. PERSONNEL SPECIFICATIONS ESSENTIAL Technical Engineering qualification at or equivalent to Level 8 degree in the National Framework of Qualifications in an approved Engineering discipline (which would include - but not exclusively - Automation Eng, Mechanical Eng, Mechatronic Eng, Manufacturing Eng, Electronic Eng, Electrical Eng, Electronic Systems, etc). 5-10 years experience in a similar management engineering role Experience in leading technical teams and interfacing with relevant cross functional departments to identify and drive process improvements. A willingness to collaborate with and influence individuals and groups in a positive, team-based environment. Excellent communication skills, both written and verbal, coupled with a high level of commitment to the delivery of projects against agreed deadlines and targets. DESIRABLE Strong technical process knowledge in automation, electronics or related areas. Knowledge of Medical Device Manufacturing or other highly regulated industry. Project Management Qualification and /or experience. Understands the requirements of process monitoring and control of validated processes. 6-sigma green/black belt and/or experience of lean practice implementation Knowledge of equipment safety standards High degree of initiative and self accountability towards the achievement of objectives. #J-18808-Ljbffr
Overview JOB TITLE: Manufacturing Engineering Technician DEPARTMENT: Engineering REPORTING TO: Lead Manufacturing Technician – Eng About Sanmina Fermoy Our Fermoy, Ireland, facility is FDA registered and certified to ISO 13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoy’s core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce. We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few. Objectives Of Position The Manufacturing Engineering Technician ensures the smooth running of all Production Equipment in a High Volume Production Environment (SMT/Clean Room or Packaging). Responsibilities To maintain Production Equipment to maximise Quality, Output and Yield, in a High Volume Manufacturing Environment, while adhering to Good Manufacturing Practices (cGMP) Guidelines. Apply Root Cause and Problem Solving to troubleshoot Production Line Issues and optimise or repair Production Equipment quickly and efficiently. Execute Preventative Maintenance activities. Liaise with Cross-Functional Teams to communicate and manage operational issues. Complete all Documentation clearly and concisely in accordance with GDP (Good Documentation Practice) Guidelines. Participate in Continuous Improvement Projects to drive Process Improvements and Efficiency in pursuit of Operation Excellence. Assist with the commissioning of new Production Equipment. Maintain appropriate stock of spare parts. Cross-Train new Manufacturing Technicians as required. Flexibility to travel to support new Production Equipment Assessments/Site Visits/Training. Any ad hoc duties as required. Assure ongoing compliance with quality and industry regulatory requirements Ensure compliance with Health & Safety Legislation and Regulations. Measurements Measurements will be assessed against an agreed set of MBO’s (Management Objectives) as detailed in the annual performance appraisal process. Personnel Specifications Essential NFQ Level 6 Qualification in Technology, Mechanical / Automation Electrical, Electronics, Mechatronics or similar (Qualified Trades Personnel with Industrial Experience will also be considered.) A Technical skillset of a Mechanical nature A “Compliance Mindset” and a high level of attention to detail in following Procedure and completing Documentation. Good communication and influencing skills. Ability to work under own initiative. Availability to work Shift Patterns. Desirable Experience in High Volume Manufacturing. Experience in High Volume Automation/Robotics/PLCs Experience in a Regulated Manufacturing Environment. Experience in Pneumatics, Electrical, Hydraulics, Vision Systems, and Workshop Machining. Understanding of Process Capability. Understanding of MSA (Measurement System Analysis) & GR&R (Gauge Repeat & Reduction) Experience in FAT (Factory Acceptance Test), SAT (Site Acceptance Test), IOPQ (Installation, Operation, Performance Qualification). #J-18808-Ljbffr
A leading manufacturing firm located in Fermoy, Ireland, is seeking a Manufacturing Engineering Technician to ensure the smooth running of Production Equipment in a high-volume environment. The candidate should have an NFQ Level 6 qualification or equivalent in a related field and possess a mechanical technical skillset. Responsibilities include maintaining equipment, troubleshooting production issues, and adhering to compliance standards. Shift pattern availability is required. This role enables you to contribute to operational excellence in a cutting-edge facility. #J-18808-Ljbffr
A leading electronics manufacturing company is seeking an IT Project Manager to manage systems implementation projects in Fermoy. The role requires a strong background in the electronic manufacturing industry, at least 3 years of relevant experience, and the ability to document and analyze business requirements. Successful candidates will possess project management skills, be fluent in English, and able to prepare high-quality presentations. This is a long-term position with flexible working hours and a competitive salary package. #J-18808-Ljbffr
A leading manufacturing company in Fermoy, Ireland is seeking a Director / Head of Engineering. You will lead a high-performing team of over 100 professionals and drive the planning and implementation of automated manufacturing solutions while ensuring compliance with quality standards for medical device manufacturing. Essential qualifications include a Level 8 engineering degree and 5-10 years of management experience. The role offers a dynamic environment with opportunities for leadership and innovation. #J-18808-Ljbffr
Job Description JOB TITLE: Director / Head of Engineering DEPARTMENT: Engineering REPORTING TO: Vice President of Operations / Plant Manager About Sanmina Fermoy Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoy’s core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce. We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few. Objectives Of Position Lead and scale a high-performing department of over 100 technical professionals across Facilities, NPI, and Advanced Manufacturing Engineering (Automation, Maintenance, Test, MES, and Product) to support existing production and future plant expansions. Act as a core member of the Senior Leadership Team (SLT) to define and implement the plant’s overall business strategy. Drive the end-to-end planning, installation, and validation of automated manufacturing solutions, utilizing World Class Manufacturing (WCM) and Lean Six Sigma methodologies to support business objectives. Develop departmental technical capabilities and roadmaps in line with Sanmina and customer requirements. Drive cross functional programs in support of continuous improvements in quality, delivery and cost. Responsibilities Direct end-to-end process development for manufacturing, test, and automation, ensuring high yield, scalability, and compliance Identify and evaluate emerging technologies and trends in manufacturing and engineering to enhance competitiveness and stay ahead of industry developments. Lead the facilities & utility Management including maintenance and support of all site utilities, Building Management Systems (BMS), and janitorial services to ensure a safe and environmentally responsible facility. CAPEX & Project Leadership for all Capital Expenditure (CAPEX) projects from scoping and business case justification through to installation and validation. Ensure ongoing compliance and engineering standards for high volume manufacturing of medical devices in ISO8 cleanrooms. Foster a high-performance culture through coaching, mentoring, career planning, and regular performance reviews to maximize individual potential Identify/sponsor or lead continuous improvement and cost reduction projects to support manufacturing of existing products. Provide both Process and Customer Support in technical, quality and commercial areas. Lead, facilitate, coordinate, and track activities required to ensure new products are completed on time, successfully, and in a manner consistent with organizational goals, plant policies, established processes, and/or the standard terms and conditions of the customer contract. Establish partnerships with key external stakeholders such as equipment suppliers and specialist material suppliers. Support customer’s visits and work with Business Development and Corporate Design teams to grow customer base. Ensure all new and existing processes are designed to comply with industry standards and H&S regulations. Support, participate & lead internal and external audit Quality Assure ongoing compliance with quality and industry regulatory requirements. Health & Safety Ensure compliance with Health & Safety Legislation and Regulations. Measurements Machine / process Uptime. Process Yield. Development of procedures and process. Completion of tasks / projects against set objectives in performance reviews. Completion of identified training programmes & development of department personnel. On-time delivery of customer expectations for NPI builds. PERSONNEL SPECIFICATIONS Essential Technical Engineering qualification at or equivalent to Level 8 degree in the National Framework of Qualifications in an approved Engineering discipline (which would include - but not exclusively - Automation Eng, Mechanical Eng, Mechatronic Eng, Manufacturing Eng, Electronic Eng, Electrical Eng, Electronic Systems, etc). 5-10 years experience in a similar management engineering role Experience in leading technical teams and interfacing with relevant cross functional departments to identify and drive process improvements. A willingness to collaborate with and influence individuals and groups in a positive, team-based environment. Excellent communication skills, both written and verbal, coupled with a high level of commitment to the delivery of projects against agreed deadlines and targets. Desirable Strong technical process knowledge in automation, electronics or related areas. Knowledge of Medical Device Manufacturing or other highly regulated industry. Project Management Qualification and /or experience. Understands the requirements of process monitoring and control of validated processes. 6-sigma green/black belt and/or experience of lean practice implementation Knowledge of equipment safety standards High degree of initiative and self accountability towards the achievement of objectives. #J-18808-Ljbffr
Job Description IT Project Manager (MES) Main Tasks Position based in Fermoy (on-site & remote split TBD). Participating-in/managing systems implementation and integration projects regarding Manufacturing Execution Systems for the EMEA region. Analyzing & documenting business requirements, defining functional requirements, preparing specifications and ensuring requirements are properly translated to technology needs. Identification of optimization for value creation in existing and new systems. Development and creation of conceptual alternatives. Creation of action plans, project plans and roadmaps to implement solutions. Participating in system/concept testing (technical, UAT). Prepare customer presentations or documentation. Proactively supporting business development activities and internal innovative initiatives. Developing strong customer and internal relationships. Desired Skills & Experience IT Degree. Min. 3 years working as IT Project Manager in the Electronic Manufacturing Industry / Manufacturing Industry. - Must Experience in the Medical Manufacturing environment - definite advantage. Solid IT background on Manufacturing Systems Integration Able to drive projects as well as produce quality customer requirements documentation Ability to understand complex issues and communicate them effectively and concisely Fast learner, high self learning abilities and good team player - Must. Ability to prepare high quality presentations in appearance and content Ability to prepare high quality analysis that is accurate and gets to the core of the analysis Ability to summarize and act on complex issues Fluent in English and ability to write in business English - Must. Confident appearance, persuasion and assertiveness Intercultural awareness Able to manage high workload and stress - Must. Technicals: Understanding of Databases & related technologies. Good understanding of technical elements of information systems AI knowledge - advantage We Can Offer Flexible working hours based on core time. Long-term position, career growing paths. Competitive salary & benefits. #J-18808-Ljbffr
A leading medical device manufacturer in the Municipal District of Fermoy, Ireland, is seeking a Laboratory Manager to oversee laboratory operations. The role requires ensuring compliance with quality and industry regulatory standards, managing a team, and maintaining laboratory efficiency. The ideal candidate will have a Level 8 Degree in Microbiology, at least 5 years of experience in a regulated environment, and strong communication and organizational skills. Competitive salary and development opportunities provided. #J-18808-Ljbffr
Job Description Job Title Laboratory Manager Department Quality Reporting To Head of Quality Individual Contributor or People Manager People Manager Objectives of Position Provide final review and approval of results, protocols, reports, SOP's etc. To act as the primary laboratory point person accountable for the team achieving a continually high standard of work. This role functions as a Subject Matter Expert (SME) to coordinate scheduling, deliver compliant products on time, and create a work environment that supports team effectiveness through coaching and mentoring. Responsibilities Maintain regulatory compliance through established programs for lab testing, environmental control, training, SOP's, technical investigations, test method validation and cleaning in a medical device regulated environment. Develop and maintain quality systems within the laboratory to ensure ongoing compliance to cGMP. Compliance with Standard Operating Procedures and Registered specifications. Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures. Issue trend reports on investigations, non-conformances. Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations. Approval of SOP’s, trend data, investigations, deviations, validation protocols, reports, method validation/verifications and equipment qualifications. Participate in regulatory agency inspections. Plan and implement procedures and systems to maximise operating efficiency. Manage and contribute to the achievements of department productivity and quality goals. Manage the scheduling and control of product testing to ensure output targets are achieved. Review and authorize records for product disposition in accordance with cGMP and defined procedures. Coordinate testing and analysis of batches to meet customer expectations. Oversee and sign off on out-of-specification investigations. Act as the primary point of contact and SME for audits and inspections. Monitor and assist hands-on in daily laboratory activities. Ensure the laboratory is maintained in a clean, audit-ready condition with sufficient consumables. Liaise with the Department Manager regarding recruitment and resource planning. Ad hoc duties as assigned by area Manager. Quality Assure ongoing compliance with quality and industry regulatory requirements. Proactively prevent or reduce non-conformances and support CAPA/change control processes. Ensure local quality requirements are considered for new or changed laboratory methods. Health & Safety Ensure compliance with Health & Safety Legislation and Regulations. Generate and maintain risk assessments for the laboratory area. Promote safety awareness and proactively reduce hazards and risks within the lab. Measurements Achievement of output targets and delivery of quality products on time. Audit readiness and successful outcomes of quality/compliance inspections. Qualifications and Experience NFQ Level 8 Degree in Microbiology or associated Life Science discipline. 5+ years microbiology work experience, ideally the majority of which in a FDA regulated environment. 2 years team lead / people management experience in microbiology testing within the laboratory is required, including conducting performance reviews. Experienced in lead the training & development of micro analysts. Experienced in the calibration and use of laboratory instrumentation, including troubleshooting equipment when problems arise. Excellent communication and presentation skills. Minimum 1 year of experience in a product testing environment with analytical instruments. Previous supervisory or leadership experience is preferred to lead and develop a team in a regulated environment. Experience running and maintaining a laboratory to GLP standards is preferred. Working knowledge of cGMP, EHS, and applicable regulatory standards. Core Competencies High attention to detail, ensures accuracy in testing and documentation. Strong organizational and practical skills with the ability to manage changing priorities. Proactive and accountable mindset regarding quality, efficiency, and safety. Strong communication and interpersonal skills for stakeholder alignment and handovers. #J-18808-Ljbffr
