Manufacturing Engineer II

Sep 3, 2025 | MANUFACTURING, RECRUITMENT

Company Overview

At FlexMedical Solutions (FMS), we help our customers bring their ideas to life and create a healthier tomorrow, by providing contract design, development, and manufacturing services to medical device OEMs.

We focus on the disposable component of diagnostic tests and have significant expertise with point of care (POC) in vitro diagnostics (IVD). We provide full assay development services and have impressive in-house manufacturing capabilities, ranging from screen printing and laser ablation of electrodes for biosensors to final device assembly, including the formulation and deposition of chemistries.

Our modern facilities are based in Livingston, central Scotland, less than 20 minutes from Edinburgh and 40 minutes from Glasgow. Further growth means that we are now expanding our operation’s capabilities and have a requirement for a talented and experienced Manufacturing Engineer. With a healthy mixture of UK and international clients, we are a forward-looking organisation with an exciting future.

 

Role Description

As an experienced engineer, you will bring hands-on, technical expertise to the company, helping us deliver on our goals and objectives. Working for a vibrant, growing organisation will provide you with a fantastic opportunity to make your mark and implement your ideas. With a strong interest in how products work, mechanically, and electrically you will be confident in creating new manufacturing processes and set up of new manufacturing equipment for our newly designed products. Your time will be spent working on some of our customer specific contracts (developing and manufacturing diagnostic products on their behalf) with a focus on transferring products, processed, and equipment from development to operations, all under ISO13485 jurisdiction.

 

Key Responsibilities

  • Interpreting customer requirements and in turn generating technical specifications and associated documents
  • Working with R&D to provide expert guidance and Design for Manufacture (DFM) input
  • Authoring documentation to permit smooth transfer of manufacture from Research and Development (R&D) to Operations. Documents will include Control Plans, Standard Operating Procedures (SOP’s) and Work Instructions (WI’s)
  • Working with engineers to ensure process and equipment validation is successfully planned and executed
  • Support manufacturing technicians to investigate, root cause and resolve any non-conformances
  • Ensuring that all Critical to Quality (CTQ) elements are established, measured, and achieved
  • Becoming expert in all key manufacturing processes and equipment
  • Ensuring that quality and regulatory procedures are always adhered to
  • Identify, propose, and implement process and efficiency improvements

 

Essential

  • A degree in a technical / engineering subject. Consideration may be given where significant industry

    • experience is demonstrated in lieu of academic qualifications

  • Demonstrable considerable experience in a similar role
  • Competent in the use of modern manufacturing equipment
  • Understand Design for Manufacture (DFM) methodology
  • Experience in process characterisation and continuous improvement
  • Experience with scaling processes from R&D/prototype through pilot to full commercial production
  • Experienced in equipment and process validation
  • Able to perform statistical analysis on data using tools such as Minitab
  • Understand current manufacturing methods including rapid prototyping
  • Experience of working to ISO13485 and 21 CFR Part 820
  • Experience conducting root cause investigations, CAPA and nonconformances
  • Highly competent with MS Office products

 

Desirable

  • Working knowledge of biosensor manufacture
  • Competent in the use of 2D/3D/CAD software such as Draftsight and Solidworks and CAM packages such as AlphaCAM
  • Hands-on experience with automation, robotics, or high-throughput manufacturing systems
  • Knowledge of reagent dispensing
  • People management experience
  • Experience of laser processing, screen printing and/or surface modification techniques
  • A Green or Black Belt qualification in six sigma / process excellence

 

Environment & Culture

FlexMedical Solutions is a young, vibrant organisation operating in a highly regulated industry. It is a changing environment that requires you to be very flexible and willing to learn and grow with the company. It is essential that you communicate with your team and contribute to the company’s success. As a provider of sub-contract services, working for FlexMedical Solutions will bring a lot of variety and excitement. Initiative will be rewarded, and personal development is guaranteed.

Apply Now

Please send your CV and a covering letter, outlining your suitability for the post:

EMAIL HERE