Operations Engineer II- Medical Device Start-up
3 days ago
Position Overview The Operations Engineer II will play a key role in establishing, optimising, and scaling manufacturing operations for a next-generation medical device. Working within a cross-functional environment, this position involves supporting New Product Introduction (NPI), process development, and manufacturing readiness to ensure robust, compliant, and efficient production processes. Key ResponsibilitiesLead and support manufacturing process development, optimisation, and validation for new and existing medical device products.Partner with R&D, Quality, and Supply Chain to support NPI and design transfer into manufacturing.Develop and document manufacturing processes, work instructions, and test procedures to ensure consistent product quality and compliance.Plan and execute process validation activities (IQ/OQ/PQ) and associated documentation.Identify and implement process improvements to enhance yield, reduce cost, and increase efficiency.Support the introduction of new equipment, tooling, and fixtures, including qualification and calibration activities.Drive root cause analysis and CAPA initiatives to resolve manufacturing or quality issues.Ensure all operations comply with relevant QMS requirements, ISO 13485, and FDA 21 CFR Part 820 regulations.Collaborate with internal and external partners (including suppliers and contract manufacturers) to ensure effective scale-up and production readiness.Support manufacturing during audits and inspections as an SME for assigned processes.Mentor and provide technical guidance to junior team members or technicians as required. Qualifications & Experience Essential:Bachelor's Degree in Engineering (Manufacturing, Mechanical, Biomedical, or related discipline).Minimum of 3 years' experience in a medical device manufacturing or operations engineering role.Proven experience supporting New Product Introduction (NPI) and process validation activities.Strong understanding of manufacturing process controls, root cause analysis, and risk management.Hands-on experience with process validation, equipment qualification, and documentation within a regulated environment.Proficiency in lean manufacturing and continuous improvement methodologies.Strong communication and interpersonal skills with the ability to work cross-functionally in a fast-paced, team-oriented environment.Desirable:Experience working with vascular, catheter-based, or electromechanical devices.Familiarity with DFSS, Six Sigma, or similar process improvement tools.Previous experience in a start-up or scale-up medical device environment. What's on OfferOpportunity to join a growing medical device start-up developing novel vascular technologies.Exposure to end-to-end product lifecycle, from concept through to commercial manufacturing.Collaborative and innovative work culture with opportunities for professional growth.At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services.
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Operations Engineer II- Medical Device Start-up
2 weeks ago
Galway, Ireland Wallace Myers International Full timeOperations Engineer II- Medical Device Start-up Permanent Galway Job Title: Operations Engineer II- Medical Device start-up Position Overview The Operations Engineer II will play a key role in establishing, optimising, and scaling manufacturing operations for a next-generation medical device. Working within a cross-functional environment, this position...
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Operations Engineer II- Medical Device Start-up
2 weeks ago
Galway, Ireland Wallace Myers International Full timeJob Title: Operations Engineer II- Medical Device start-up Position Overview The Operations Engineer II will play a key role in establishing, optimising, and scaling manufacturing operations for a next-generation medical device. Working within a cross-functional environment, this position involves supporting New Product Introduction (NPI), process...
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R&D Engineer II
2 weeks ago
Galway, Ireland Wallace Myers International Full timePosition: R&D Engineer II - Medical DevicesLocation: Galway, Ireland Position Summary The R&D Engineer II will support the planning and execution of medical device development, including preparing and reviewing documentation, collaborating with component suppliers, working with functional engineering teams to create detailed designs, and supporting products...
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R&D Engineer II
4 weeks ago
Galway, Ireland Wallace Myers International Full timePosition: R&D Engineer II - Medical Devices Location: Galway, Ireland Position Summary The R&D Engineer II will support the planning and execution of medical device development, including preparing and reviewing documentation, collaborating with component suppliers, working with functional engineering teams to create detailed designs, and supporting products...
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Galway, Ireland Wallace Myers International Full timePrincipal Engineer - Process Development Role Overview The Principal Engineer - Process Development will lead manufacturing engineering activities, own process development for new devices, and drive continuous improvement across production systems. This role requires a hands-on engineer who thrives in a fast-paced environment, enjoys cross-functional...
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Manufacturing Engineer
3 weeks ago
Galway, Ireland CREGG Full timeManufacturing Engineer (Medical Devices) Our client, a global leader in medical device industry based in Galway, is looking for skilled Quality Engineers / Manufacturing Engineers. This is an excellent opportunity to work onsite and partner closely with manufacturing and quality teams to strengthen compliance and support process validation projects. For...
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Electronics Engineer
4 weeks ago
Galway, Ireland CREGG Full timeOverview Electronics Engineer Our Galway based world leading multinational medical device manufacturing client seek an experienced Electronics Engineer to join their team. Please send CV to rachel@cregg.ie to discuss About the Role This role is based in the growing Structural Heart Department of our Galway based client. 9 hour work week with a 1pm Friday...
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Product Development Technician II
4 weeks ago
Galway, Ireland Life Science Recruitment Full timeJob title: Product Development Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and...
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R&D Technician II
5 days ago
Galway, Ireland Life Science Recruitment Full timeJob title: Product Development Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and...
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Quality Engineer II: Lead Quality
2 weeks ago
Galway, Ireland Boston Scientific Gruppe Full timeA leading medical technology company in Galway is seeking a highly motivated Quality Engineer II to ensure compliance with quality systems and regulations. The ideal candidate will have over 5 years of experience in the Medical Device industry and a strong understanding of quality assurance practices. This position offers the opportunity to contribute to...
