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 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 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, 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 to your working day. Initiative will be rewarded and personal development is guaranteed.

The post R&D Scientist 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 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 at the same time.

Key Responsibilities

You will be responsible for: –

• Designing and developing solutions to complex challenges
• Designing and executing technical feasibility experiments
• Interpreting customer requirements and in turn generating 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
• Leading work packages and supporting less experienced colleagues
• Effective management of several client projects simultaneously
• Ensuring that quality and regulatory procedures are always adhered to

Skills, Knowledge, and Experience required

Essential

• A degree in a technical / engineering subject. Consideration may be given where significant industry experience can be demonstrated in lieu of academic qualification
• Demonstrable considerable proven experience in a similar role
• Be fully versed and competent in the use of modern manufacturing equipment (e.g., lasers, robotics, liquid dispensing) and metrology equipment (e.g. CMM, contact angle)
• Understand and practice Design for Manufacture (DFM) methodology
• Be competent in the use of 2D/3D/CAD software such as Draftsight & Solidworks and CAM packages such as AlphaCAM
• Confidently 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
• People management experience

Desirable

• Working knowledge of biosensor design and development
• Experienced in product and process validation
• Experience in laser processing, screen printing or surface modification techniques
• Experience of Twincat PLC programming
• Knowledge of robot system programming e.g. Universal Robots
• 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 great deal of variety and excitement to your working day. Initiative will be rewarded and personal development is guaranteed.

The post Product Development Engineer 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.

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 qualified scientist you will bring hands-on technical expertise to the company and will have previously managed complex technical projects in IVD.

Having gained extensive experience in the laboratory, you will understand how to develop commercial in-vitro diagnostics and will have specific experience in electrochemical and other common assay detection methods.  With an interest in how products work chemically, fluidically, and mechanically it is expected that your experience goes beyond the lab, and you will operate comfortably as both scientist and project manager, managing and supporting your team to achieve successful and timely outcomes.  Your time will be spent working on customer specific contracts (developing and manufacturing diagnostic products on their behalf) and working on internal development programmes.

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.  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 CTO, you will: –

• Manage a team of scientists to successfully achieve project outcomes efficiently and within timescale.
• Manage project staff to rapidly identify, root cause and mitigate technical problems in complex biosensor programmes.
• Design reagents and sensors capable of reliable and safe measurement of analytes.
• Development of electrochemical, enzymatic, colorimetric, and immune assays.
• Quickly understand client’s biochemical pathways and be able to critique and plan improvement approach.
• Collaborate with engineering to ensure electrodes and fluidic cells can deliver sample and reading output from biochemical assays across a range of detection systems (echem, fluorescence, etc).
• Demonstrate effective lab craft, operating successfully in both the lab and office environment.
• Develop and execute electrochemical methods for external customer requirements, and internal development programmes.
• Drive experimental design to make swift robust technical design decisions.
• Produce all necessary documentation required for product technical files (design history files).
• Provide impactful and diligent updates for internal and external stakeholders.
• Work with clients to ensure robust and product focused technical work is scheduled and executed effectively.
• Author, oversee, and execute protocols and reports (R&D, Verification, Validation, SOPs).
• Develop product and process technical documents to successfully introduce new products and processes into manufacturing.
• Communicate effectively with sub-contractors, suppliers, and customers.
• Provide scientific and project direction to team members, ensuring problems are quickly resolved and designs evolved to improve performance.
• Provide scientific input into product and process designs, ensuring optimal performance and client satisfaction.
• Produce characterisation reports for customer products and development reports for internal programmes aligned to the Quality Management System.
• Drive projects and teams with a daily mindset.

Skills, Knowledge and Experience required

Essential

• Qualified to degree level as a minimum in a relevant scientific subject (in lieu of academic qualification, we will consider candidates with significant and demonstrable experience in the IVD industry)
• Experience of working in a similar role within the IVD industry
• Experience of managing staff to produce high performing teams, including undertaking recruitment, actively developing team members, conducting appraisals, and managing performance and conduct matters
• Experienced in designing reagents and formulations from first principles
• Experience in electrochemical assay development and other detection systems in IVD
• Have experience in IVD product development and validation, and the complete design control lifecycle
• Be competent using laboratory test apparatus such as potentiostats and spectrophotometers
• Experience of statistical analysis on data, and presenting high level communication summaries
• Understand Good Laboratory and Good Manufacturing Practices (GxP)
• Experience of working to ISO13485 and 21 CFR Part 820 and familiarity with product and process validation.

Desirable

• Experience of launching point of care platforms
• Understand Design for Manufacture (DFM) methodology
• Experienced using statistical tools such as Minitab and understands Design of Experiments approach to optimisation
• Experienced in reagent chemistry as applied in IVD products
• Experienced in surface chemistry: modification and analysis
• Management of a commercial IVD product development through to launch
• A Green or Black Belt qualification in six sigma / process excellence
• Experience of operating in a project management environment where “Daily Management” is the norm.

Environment & Culture

FlexMedical Solutions is an evolving, scaling organisation operating in a highly regulated industry.  The company is enjoying growth through success and is working on several leading edge projects with particularly exciting customers.

It is a changing environment that requires you to be very flexible, resilient, and willing to learn and grow with the company.  It is essential that you communicate with your colleagues 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 Technical Lead 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.

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 significantly experienced scientist you will bring hands-on technical, and strategic expertise to the company.

Having demonstrated superior skill in the lab through multiple programmes, you will be skilled in the development of in-vitro diagnostics and will have specific experience in reagent development for common assay detection methods such as e-chem, fluorescence, chemiluminescence. You will be engaged in customer specific contracts, developing and producing diagnostic products on their behalf, in addition to internal development activity.

As a contract business, we work on numerous projects with several clients simultaneously. This brings a lot of variety and requires people who are both willing and capable of working on concurrent multiple projects.

Working for a scaling organisation will provide you with a fantastic opportunity to make your mark and implement your ideas, helping to steer the company’s technical direction.

Key Responsibilities

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

• Manage significant bodies of work within major projects, and / or manage complete minor projects and all associated client relationships and design control responsibility.
• Design and build reagents necessary to facilitate biochemical reactions as part of an IVD development.
• Develop and execute electrochemical testing experiments, aligned to the needs of the projects.
• Translate wet chemistry design and performance to dry chemistry formats to ensure retention of performance and reliability of low cost biosensors for a range of sample types.
• Write and execute R&D protocols and where necessary verification protocols.
• Execute and report lab experiments in support of external client projects and internal development programmes.
• Provide scientific input into product and process designs ensuring optimal performance and client satisfaction.
• Supervise and mentor less experienced members of the technical team, ensuring their work meets quality expectations and is aligned to project critical paths.
• Lead by example technically and non-technically, especially within the lab, and ensure company values are upheld.
• Prepare and supply reports to internal and external stakeholders.
• Independently and rapidly root cause and robustly resolve technical challenges within projects to maintain timelines.
• Transfer technical design and processes into routine manufacturing.
• Produce characterisation reports for customer products and development reports for internal programmes aligned to FMS’s 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.
• For larger projects, you may also be required to manage and develop others.

Skills, Knowledge and Experience

Essential

• As a minimum, you will hold a degree level qualification in a relevant scientific subject (in lieu of academic qualification, we will consider candidates with significant similar industry experience)
• Significant, demonstrable, relevant experience gained in a regulated environment
• Experienced in designing and building biochemical reagents and formulations from first principles
• Experienced in electrochemical methods and other complex IVD detection formats
• Experienced in rapid prototyping of novel biosensors or IVDs
• Experienced in protein chemistry and / or surface chemistry and analysis
• Experienced in IVD product development in a commercial setting
• Competent using complex laboratory equipment such as Spectrophotometers, potentiostats, and HPLC/FPLC systems
• Able to process raw data and summarize findings effectively to drive complex decision making necessary optimise IVD design
• Understand and exercise Good Laboratory and Good Manufacturing Practices (GxP)
• Experienced working to ISO13485 and / or 21 CFR Part 820, and familiar with design control and product & process validation
• Experienced in planning complex bodies of work and effectively working to planned timescales, communicating the plan, and tracking progress.

Desirable

• A Green or Black Belt qualification in Six Sigma / process excellence
• Competent in the use of modern manufacturing equipment e.g. lasers, dispensing, lamination & assembly
• Understand Design for Manufacture (DFM) methodology and have experience in implementation
• Experienced in using statistical tools such as Minitab and understand Design of Experiments methods (DoE)
• Experienced in optimisation of screen printed electrodes for biosensor applications
• Project Management experience
• People management experience.

Environment & Culture

FlexMedical Solutions is a scaling organisation, operating in a highly regulated industry. The company is enjoying growth through success and is working on several 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 great deal of variety and excitement; initiative will be rewarded, and personal development is a given.

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