Manufacturing Engineer
hace 3 días
Livingston
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 II, 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. Desirable • Knowledge of biosensor manufacture., • CAD/CAM skills (Draftsight, Solidworks, AlphaCAM)., • Experience with automation, robotics, or high-throughput systems., • Familiarity with laser processing, screen printing, or reagent dispensing., • Six Sigma (Green/Black Belt) qualifications. 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 / 07495896347.