Product Development Engineer I

Flexmedical Solutions; Livingston; On-site; GBP 40,000 - 60,000; Full time

Job summary

Flexmedical Solutions in Livingston is seeking an experienced engineer to contribute to the development of diagnostic products. The role includes working closely with Senior Engineers to tackle engineering challenges, conducting feasibility studies, and ensuring compliance with quality standards.

The ideal candidate should have a technical degree, proven experience in manufacturing, and the ability to perform detailed analyses using modern tools. This is an excellent opportunity within a vibrant organization focused on innovation.

Qualifications

• Degree in technical/engineering field or significant industry experience.
• Proven experience in a similar industry.
• Competence in using modern manufacturing equipment.
• Ability to communicate effectively with clients and suppliers.

Responsibilities

• Develop solutions to complex engineering challenges.
• Execute technical feasibility experiments.
• Generate technical specifications and documents.
• Produce detailed reports and presentations for projects.

Skills

Manufacturing equipment usage

Statistical analysis using Minitab

2D/3D/CAD software (Draftsight, Solidworks)

Understanding of manufacturing methods

Biosensor design and development

Design for Manufacture (DFM) methodology

Experience with ISO13485 and 21 CFR Part 820

Education

Degree in a technical/engineering subject

Tools

Laser processing equipment

Metrology equipment (CMM, contact angle)

Robotics for manufacturing

Job description

At FlexMedical Solutions, 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 the medical device and have significant expertise with point of care (POC) in vitro diagnostic (IVD) tests. Our in‑house capabilities range from screen printing and laser ablation of electrodes for biosensors to final device assembly, including the formulation and deposition of chemistries.

Our modern facility is based in Livingston, central Scotland, less than 20 minutes from Edinburgh airport and 40 minutes from Glasgow. Further growth means that we are now developing our capabilities in product development. With a 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 chemically, mechanically, and electrically you will be confident in creating new manufacturing processes for your 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 activities extending from early concept to full scheduled development and manufacture, all under ISO13485 jurisdiction.

You will be adept at successfully managing several client projects simultaneously.

Key Responsibilities

You will be responsible for: –

• Working with Senior Engineers to develop solutions to complex challenges
• Designing and executing technical feasibility experiments
• Supporting senior engineers to generate technical specifications and associated documents
• Providing detailed, technically thorough reports and presentation
• Authoring, overseeing and executing protocols
• Communicating effectively with sub‑contractors, suppliers and clients
• Developing product and process technical documents to successfully introduce new products into manufacturing, including validation protocols and reports
• Ensuring that quality and regulatory procedures are always adhered to

Skills, Knowledge, and Experience required

• You will hold a degree in a technical / engineering subject. Although consideration will be given where significant industry experience is demonstrated in lieu of academic qualification.
• Proven, demonstrable experience in a similar industry
• Competent in the use of modern manufacturing equipment (e.g. lasers, robotics, liquid dispensing) and metrology equipment (e.g. CMM, contact angle)
• Competent in the use of 2D/3D/CAD software such as Draftsight & Solidworks
• Able to perform statistical analysis on data using tools such as Minitab
• Understand current manufacturing methods including rapid prototyping
• A working knowledge of biosensor design and development
• Understand Design for Manufacture (DFM) methodology
• Experience in product and process validation
• Experience in laser processing, screen printing or surface modification techniques
• A Green or Black Belt qualification in six sigma / process
• Experience of working to ISO13485 and 21 CFR Part 820

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 great deal of variety and excitement. Initiative will be rewarded and personal development is guaranteed.