Manufacturing Project Engineer

FlexMedical Solutions helps customers bring their ideas to life and create a healthier tomorrow by providing contract design, development, and manufacturing services to medical device OEMs. Specialising in disposable components for point-of-care IVD diagnostic tests, offering full assay development and advanced manufacturing capabilities — from screen printing and laser ablation of biosensor electrodes to chemistry deposition and final device assembly. The business is based in Livingston and supports a growing base of UK and international clients. We are looking for a talented Manufacturing Engineer to join the dynamic team to work in a fast-paced environment. As a Manufacturing Engineer, you will be a key technical contributor, transforming product concepts into robust, scalable, and compliant manufacturing processes. Working closely with R&D, Quality, and Operations, you'll take ownership of process development, validation, and continuous improvement – ensuring the build of world-class diagnostic devices efficiently and consistently. This is a hands-on role in a rapidly growing organisation where your expertise, initiative, and problem-solving skills will have real impact. Key Responsibilities Lead the design, refinement, and optimisation of manufacturing processes for new and existing diagnostic products. Act as the technical bridge between R&D and Operations, ensuring smooth product transfer and scale-up. Develop and maintain comprehensive process documentation, including Control Plans, SOPs, and Work Instructions. Plan and execute process and equipment validation (IQ/OQ/PQ) in line with ISO13485 and GMP. Use structured problem-solving tools (5-Why, FMEA, RCA) to investigate issues and prevent recurrence. Drive continuous improvement initiatives using lean and Six Sigma methodologies. Monitor and analyse Critical-to-Quality (CTQ) metrics to identify optimisation opportunities. Collaborate cross-functionally to implement scalable production solutions. Contribute to a culture of agility, ownership, and continuous learning within the technical team. About You Essential Skills & Experience Degree in Engineering or a related technical field (or equivalent practical experience). Proven experience in a hands-on manufacturing engineering role, ideally in a regulated or GMP environment. Strong analytical mindset with the ability to apply data-driven decision-making. Demonstrated experience in Design for Manufacture (DFM) and scaling processes from prototype to volume. Excellent communication, documentation, and organisational skills. Comfortable working at pace and managing multiple simultaneous projects. Self-motivated, curious, and adaptable — eager to learn new systems and technologies. Desirable Knowledge of ISO13485, 21 CFR Part 820, or other regulated standards. Experience with biosensors, microfluidics, or diagnostic device manufacture. Understanding of validation lifecycle (IQ/OQ/PQ). Exposure to automation, robotics, reagent dispensing, or high-throughput production processes. Six Sigma Green/Black Belt or proficiency with tools such as Minitab. Experience mentoring or supporting junior technical team members. Why Join? FlexMedical Solutions offers a vibrant, collaborative culture with opportunities to learn, grow, and make an impact. Working here provides variety, exposure to cutting-edge diagnostics, and the chance to contribute directly to improving healthcare. Initiative is rewarded, and personal development is guaranteed. To apply or discuss further, please contact Natalie Fox nf@kleboejardine.com / 07495896347.