Manufacturing Project Engineer

FlexMedical Solutions (FMS) helps customers bring their ideas to life and create a healthier tomorrow by providing contract design, development, and manufacturing services to medical device OEMs. With expertise in disposable components of diagnostic tests and point-of-care in vitro diagnostics (IVD), FMS offers full assay development services and state-of-the-art manufacturing capabilities — from screen printing and laser ablation of electrodes to final device assembly and chemistry deposition. We’re a young, dynamic company with UK and international clients, offering an exciting future for our growing team. The Role As a Manufacturing Engineer , you will bring hands-on technical expertise to support the transfer of products, processes, and equipment from development into operations — all under ISO13485. You’ll collaborate with R&D teams, support technicians on the shop floor, and play a key role in validation, process improvement, and scaling manufacturing for new diagnostic products. This is an opportunity to work in a fast-paced, highly regulated environment where your input and initiative will have real impact. Key Responsibilities Interpret customer requirements and generate technical specifications. Provide Design for Manufacture (DFM) guidance to R&D teams. Author technical documentation (Control Plans, SOPs, Work Instructions). Plan and execute process and equipment validation. Support technicians to investigate and resolve non-conformances. Establish and monitor Critical to Quality (CTQ) parameters. Identify and implement process improvements. Ensure compliance with ISO13485 and regulatory standards. About You Essential Skills & Experience Degree in an engineering/technical subject, or equivalent industry experience. Strong experience in a similar manufacturing role. Proficiency with modern manufacturing equipment and process scaling. Skilled in equipment and process validation. Knowledge of ISO13485 and 21 CFR Part 820. Competent in statistical analysis (e.g. Minitab). Experience with root cause investigations, CAPA, and non-conformances. 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.

Location: Livingston, Scotland, GB

Posted Date: 11/16/2025