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.