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

Essential

• 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

Desirable

• 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
• People management experience
• Experience of working to ISO13485 and 21 CFR Part 820

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

The post Product Development Engineer I appeared first on FlexMedical Solutions.

Company Overview

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 diagnostic devices 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 expanding our premises, capabilities, and systems. With a mixture of UK and international clients, we are a forward-looking organisation with an exciting future.

Role Description

As a qualified scientist you will bring hands-on, technical expertise to the company.

Having gained experience in the laboratory, you will understand in-vitro diagnostics and may have some specific experience in electrochemical and other common assay detection methods. With an interest in how products work chemically, mechanically, and electrically it is probable that your work experience goes beyond the lab.

As a contract business, we work on multiple projects simultaneously. This brings a lot of variety and requires people who are both willing and able to develop new products and processes in unison with our design control process. Your time will be spent working on some of our customer specific contracts (developing and manufacturing diagnostic products on their behalf) and working on internal development programmes.

Working for a scale-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.

Key Responsibilities

Reporting to the Technical Lead/CSO, you will: –

• Design and build reagents / formulate customer solutions to their requirements.
• Develop and execute electrochemical methods for external customer requirements, and internal development programmes.
• Develop reagent deposition methods and sensor build processes, to ensure rapid, consistent, and precise sensor production for development programmes.
• Work with clients to devise and execute experimental designs (DoE’s) and create summary reports for discussion.
• Author, oversee and execute protocols and write reports.
• Develop product and process technical documents to successfully introduce new products and processes into manufacturing.
• Communicate effectively with sub-contractors, suppliers, and clients.
• Provide scientific input into product and process designs ensuring optimal performance and client satisfaction.
• Produce characterisation reports for customer products and development reports for projects, aligned with FMS design Quality Management System.
• Stay informed of latest developments and trends in your field e.g. current trends and methods in IVD development through routine review of current scientific literature.

Skills, Knowledge, and Experience required

Essential

• As a minimum, you will hold a degree level qualification in a relevant scientific subject.
• You will have demonstrable, relevant experience gained in a regulated environment. However, consideration will be given where relevant academic experience can be demonstrated in lieu of industry experience.
• Competent using routine and complex laboratory equipment.
• Experienced in designing and building reagents and formulations from first principles.
• Significant experience in electrochemical methods or other test measurement systems.
• Experience of designing experimentation to resolve technical uncertainty through scientific rigor and root cause analysis.
• Experience in IVD product development and familiar with Design Control concept.
• Able to perform statistical analysis on data to drive decision making.
• Understand Good Manufacturing and Good Laboratory Practices (GxP).
• Experience of working to ISO13485 and / or 21 CFR Part 820, and familiar with product and process validation.

Desirable

• A Green/Black Belt qualification in Six Sigma / process excellence is highly advantageous.
• Competent in the use of modern manufacturing equipment (e.g. lasers, dispensing, lamination assembly).
• Understand Design for Manufacture (DFM) methodology.
• Experienced using statistical tools such as Minitab and understand Design of Experiments methodology.
• Experienced in reagent chemistry as applied in IVD products.
• Experienced in surface chemistry: modification and analysis.
• Experience in microfluidic devices.
• People management experience would be advantageous.

Environment & Culture

FlexMedical Solutions is a young and evolving start up organisation, now scaling, and operating in a highly regulated industry. The company is enjoying growth through success and is working on a number of leading edge projects with exciting customers.

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 a given.

The post R&D Scientist II appeared first on FlexMedical Solutions.

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. Our main focus is on Point of Care (POC) in vitro diagnostic (IVD) tests.

In our role as a Contract Development and Manufacturing Organisation (CDMO), 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 inhouse engineering and manufacturing capabilities, allowing us to fabricate biosensors and assemble finished test cartridges; indeed, this extends to the formulation and deposition of
chemistries.

Our modern facilities are conveniently located in Livingston, central Scotland, less than 20 minutes from Edinburgh and 40 minutes from Glasgow. With a healthy mixture of UK and international clients, we are a forward-looking organisation with an exciting future.

Role Description

As a recently qualified scientist you will bring technical expertise to the company. With undergraduate experience in the laboratory, you may already have some understanding of invitro diagnostics and may have some specific knowledge in electrochemical and other common assay detection methods.

You will have an interest in how products work chemically, mechanically, and electrically. As such, you will spend time in other areas, namely operations and engineering, developing your knowledge of our processes and business.

As a contract business, we work on multiple projects simultaneously; this brings a lot of variety and requires people who are both willing and able to develop new products and processes in unison with our design control process. Your time will be spent working on some of our customer specific contracts, developing and manufacturing diagnostic products on their behalf, and working on internal development programmes. Working for a scaling organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.

Key Responsibilities

Reporting to the R&D Senior Scientist or R&D Technical Lead, you will: –

• Build reagents / formulate customer solutions to their requirements
• Execute electrochemical methods for external customer requirements, and internal development programmes
• Perform tasks on FMS dispensing systems to accurately deposit solutions and perform subsequent gravimetric analysis
• Manage all on-site chemicals / reagents with regards to inventory, H&S, storage, and containment
• Execute protocols and summarise the outcome in formal reports
• Execute and report lab experiments in support of external client projects and internal development programmes
• Document project work in a compliant manner and in line with the FMS quality management system
• Provide scientific input into product and process designs ensuring optimal performance and client satisfaction
• Initiate non-conformance reports as and when required
• Support routine product manufacturing where required.

Skills, Knowledge and Experience

Essential

• A degree in a relevant scientific subject
• Competent using routine laboratory equipment
• Some experience in building reagents and formulations from first principles (buffers)
• Able to summarise and perform basic statistical analysis on data
• Able to record data and report outcomes in a compliant manner

Desirable

• Work experience in a regulated environment (such as IVD)
• A keen interest in IVD products and their development
• A keen interest in electrochemical methods and other IVD detection systems such as fluorescence. chemiluminescence, optical lateral flow devices
• Knowledge of protein conjugation and purification
• Organic chemistry understanding
• Understand Good Manufacturing and Good Laboratory Practices (GxP)
• Understand Design for Manufacture (DFM) methodology
• Understand Design of Experiments methods
• Experience of using statistical tools such as Minitab

Environment & Culture

FlexMedical Solutions is a young, evolving and scaling organisation operating in a highly regulated industry. The company is enjoying growth through success and is working on a number of leading edge projects with some very exciting customers.

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 a given.

The post Graduate Associate Scientist (hiring 2 positions) appeared first on FlexMedical Solutions.