Job Description

Job Description

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 nf@kleboejardine.com / 07495896347.