Senior Manufacturing Engineer - GalwayOur client is a fast-growing medical technology company on a mission to transform how patients experience cancer treatment. They design and build breakthrough technologies that enable healthcare providers to deliver care that is more effective, accessible, and cost-efficient.As the company approaches key milestones in product development and commercialization, they are seeking a Senior Manufacturing Engineer to lead manufacturing and process development for their latest device—a pioneering technology that enables cancer care in the home.This role offers the opportunity to be part of a rapidly scaling organization, working at the intersection of R&D, Quality, Design Assurance, and Operations to bring life-changing technologies to patients.Why Join This Client?Impactful Work: Contribute to the development and delivery of high-impact medical devices that make a real difference to patients.Growth Opportunities: Comprehensive training and continuous personal and professional development are embedded in the company’s culture.Flexibility and Benefits: A competitive salary, strong benefits package, flexible working hours, and a generous vacation policy are all part of the offer.Early Influence: As a key hire, you will have the chance to shape manufacturing processes and influence the growth trajectory of an innovative start-up.Key ResponsibilitiesCollaborate with R&D on optimizing product designs for manufacturability (DFM) and assembly (DFA).Establish and validate a new assembly line within a Class 8 cleanroom, including jig and fixture design.Lead equipment and process validation for device assembly.Support builds for R&D testing, product verification, validation, clinical trials, and commercial launch.Develop robust work instructions, test methods, and process controls.Drive root cause investigations and resolve process non-conformances.Manage timelines for manufacturing projects and coordinate with external suppliers.Continuously identify and implement manufacturing process improvements.Utilize CAD tools and in-house prototyping equipment to design and refine fixtures.Ensure delivery of projects on time, on cost, and to quality standards.Candidate ProfileThe ideal candidate will be:Creative – a resourceful problem solver with a passion for innovation.Open – collaborative, positive, and receptive to constructive feedback.Communicative – skilled in written and verbal communication across teams.Self-Driven – proactive, accountable, and motivated to take ownership.Organised – capable of managing priorities and meeting deadlines.Team-Oriented – thrives in multidisciplinary, mission-driven environments.Experience RequiredDegree in Engineering or a related technical discipline.6+ years of relevant experience in a manufacturing environment, with at least 3 years in the medical device industry.Proven expertise in:ISO13485 or equivalent quality management systems.Cleanroom assembly and polymer processing.Process and equipment validation.Root cause investigations and process optimization.Managing external suppliers.Additional AdvantagesAdvanced qualification (Masters or Diploma) in a technical field.Experience with PCBs and/or electromechanical components.Cleanroom design and assembly line configuration.Previous start-up or SME experience.Prototyping experience (3D printing, vacuum forming, heat sealing).Supplier process validation (e.g., injection moulding).Leadership in line installations, transfers, or new process development.Familiarity with Lean manufacturing tools and methods.
#J-18808-Ljbffr