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.

In our role as a Contract Development and Manufacturing Organisation (CDMO), 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 facilities are based in Livingston, central Scotland, less than 20 minutes from Edinburgh 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 an experienced and confident Programme Manager, you will bring project management and technical expertise to the company. Having demonstrated significant project organizational skills via delivery of multiple projects, you will understand what it takes to meet client requirements at all stages of the project lifecycle from securing of contract, through design and development, to routine manufacture.

As a contract business operating in the highly regulated field of medical devices, we work on numerous projects with several clients simultaneously. This brings a lot of variety and requires people who are both willing and able to manage significant complexity.

Working for a scale-up organization will provide you with a fantastic opportunity to make your mark and implement your ideas, helping to affect the company’s performance. Your time will be spent guiding a multidisciplined group in a matrix management structure.

Key Responsibilities

Reporting to the CTO and/or Senior Programme Manager, you will:-

General Project Leadership:

• Assume the project lead and primary contact role with at least one major client or
• Ensure all contractual obligations are delivered by both FMS and the
• Ensure timely delivery of projects and services to the
• Assume P&L responsibility for allocated
• Working within a matrix, help coordinate a cross-functional group including science, engineering, supply chain, operations and quality colleagues to deliver project objectives.
• Contribute to the technical day to day running of the project where you will be accountable but not responsible for technical delivery.
• Work closely with functional managers to ensure project objectives are achieved within the contracted timelines and budgets.

Initiation & Planning:

• Lead project kick‑off activities, ensuring all stakeholders understand objectives, scope, timelines, and roles.
• Establish project governance, communication channels, and documentation standards.
• Develop, and maintain, an effective plan (Gantt) to deliver the project.
• Ensure suitable skills are represented in the project team and escalate where a skill is required.
• Input into the planning and execution of technical activity.

Delivery:

• Implement and maintain effective project governance (internal/external project meetings; internal/external management reviews). Making use of such milestones, KPIs, and performance metrics as are required to assure progress aligns with the project plan.
• Ensure decisions and actions are documented and subsequently completed.
• Constructively contribute to technical decision making on projects, using your experience and gaining new technical knowledge.
• Record, assess, and communicate programme/project risks and issues. Work with the team to develop mitigation and contingency plans escalating effectively through governance. 
• Facilitate clear, timely communication across project teams and stakeholders (internal and external)
• Ensure quality assurance deliverables are met – making effective interventions and escalations as required.
• Track project revenues and costs and report up for monitoring.
• Where milestone, KPI and performance metrics indicate progress does not match with Customer requirements, work with project resources to clarify the circumstances, assess the impact on scope, schedule, cost, and resources, and define next steps – including agreeing if a technical change is required to be notified to client and agreed.
• Where projects revenues and costs cannot be maintained in line with budgets, work with project resources to clarify the circumstances, assess the impact and define the resource/cost requirements to assure Customer outcomes – including recommending if a commercial change is required to be notified to Customer and agreed.
• Beneficially manage client change requests, securing client alignment, delivering accurate impact assessments (technical and project) and oversee implementation.

Other

• Provide accurate, effective updates – explaining technical (or commercial) updates and the associated impact in plain language – accessible to the audience. From time to time it may be appropriate to delegate an update to technical team member – however you should be able to bridge the gap for non-technical stakeholders.
• Within FMS, act as the advocate for client’s contracted deliverables and experience throughout the programme/project delivery lifecycle.
• Beneficially manage the Customer’s experience of product or service delivery and ensure that FMS’s expertise in solving complex, unanticipated programme or project issues is understood and appreciated by client stakeholders.
• Show leadership on defining, role-modelling and mentoring on project leadership and aligned with whats expected by FMS.
• Contribute to the definition and delivery continuous improvement opportunities in respect to delivery and quality of projects
• As a technically skilled individual, continue to bring that knowledge to the team to ensure the right technical outcome.
• Ensure customer feedback is captured, communicated, and integrated into project decision.

Skills, Knowledge and Experience

Essential

• Be qualified in an engineering or scientific discipline to bachelor’s degree level as a minimum (significant industry experience may be considered in lieu of formal qualifications).
• You will be able to demonstrate significant experience in a project management role within a contract design, development, and manufacturing organisation in a highly regulated industry
• Have excellent organisational skills
• Demonstrate and role model project energy and be technically present 100% of the time.
• Have excellent communication skills both written and oral, and be entirely confident and engaging, meeting senior level client executives, and representing FMS
• Be able to compile reports concisely and present them confidently, both internally and externally
• Have excellent project management skills
• Be technologically competent and be comfortable reading and understanding technical documents
• Experienced with ISO13485 and / or 21 CFR Part 820 and be familiar with design control and product and process validation

Desirable

• Prince2 project management (or equivalent) qualified
• Have excellent financial skills and be able to interpret profit and loss accounts, identifying areas for risk and action
• Understand Design for Manufacture (DFM) methodology and have experience in implementation
• Have experience working in a POC IVD product development.
• Have launched commercial IVD products
• Understand microfluidics, surface chemistry, electrode / biosensor design and manufacture
• Experience in a contractual or financial side of the role
• A Green or Black Belt qualification in six sigma / process excellence
• People management experience

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 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 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 is rewarded, and personal development is a given.

When developing a point-of-care diagnostic, decisions about the instrument, the consumable, and the chemistry are more closely connected than is often recognised. Temperature (as a key reaction variable) is one example. Considering it alongside the rest of the system early can change what the product looks like by the time it reaches manufacturing.

Why temperature matters

Chemical reactions are driven by temperature (higher temperature, faster reactions). In diagnostics, changes in reaction temperature will affect the test result and how reliably it can be read. As temperature drifts, the result drifts too. This impacts all aspects of a device’s analytical performance.

Three approaches

In our view, there are three broad ways to manage temperature as a critical parameter: control temperature directly, holding the reaction at the level it needs; compensate for temperature, measuring temperature and correcting the biased result via an algorithm; or reduce how much time the reaction has to be affected by it, by making the reaction so fast that small changes in ambient temperature are not significant to the accuracy of the result.

Each comes with a different trade-off. Direct control is generally the most reliable route, because it removes the variable rather than working around it, but it usually costs more to build in (enhanced hardware required). Compensation is cheaper to add, but depends on how well the correction model matches the real behaviour of the reaction, which isn’t always straightforward, and still leads to a limited ambient operating range. Compensation also requires a two-dimensional algorithm that characterises the temperature effect across the anticipated concentration range (this is because of the non-linear reaction rate of most chemistry pathways). Minimising reaction time reduces the amount of time the reaction is affected by temperature, but only works if the chemistry allows it (don’t try this with Troponin!). This is good for some enzymatic assays and ISEs. None of the three is universally right. Which one fits depends on the assay, the budget, and how much Total Error the analyte can tolerate.

Where does the control belong?

Assume direct control is the preferred approach for a given product. That still leaves a design decision: does the heating element belong in the reusable instrument, or can it sit on the disposable itself (interesting!)?

Instrument-side heating is the conventional route, and a proven one, but it adds significant cost to the instrument (and will zap the battery of your portable device!). It also has the limitation that the heater is located a distance away from the reaction, and the heat sometimes needs to pass through multiple layers of plastic and air (which unfortunately are great insulators!). It’s also imperative to include temperature monitoring to enable feedback circuitry to adjust the drive current of the heater to ensure the actual temperature is achieved.

Onboard heating in disposable electrodes

This is where onboard microheaters come in. Rather than heating the reaction from the instrument, a microheater built directly into the consumable applies localised, low-power heating within the test strip itself. Because these are on-strip, each strip lot can have a TCR (temperature coefficient of resistance) calibration performed, meaning the temperature experienced at the reaction site is characterised, thus removing the need for onboard temperature measurement and feedback to adjust the drive current. The drive current to achieve the right temperature is set during lot calibration. This works, but it increases the development time and device cost for the consumable. However, it simplifies the instrument and reduces its cost (if this is a client requirement).

We’ve been producing onboard-heated electrodes as part of our biosensor fabrication work, and it’s changed how we think about where thermal control should sit in a system, not as a fixed rule, but as a genuine design choice. For this option, it is critical to fully characterise the temperature coefficient of resistance (TCR) for our range of microheater electrode designs we can deploy to client biosensors. This allows us to choose the right option based on clients’ needs (though they still typically require fine-tuning for each given application).

Think about the system early

Which brings this back to where it started. This isn’t a decision to make late in a project, once the instrument and the chemistry have already been designed separately. Temperature, the disposable, and the instrument are part of the same system, and treating them that way from the outset gives the development team more opportunity to make informed decisions before the system architecture becomes difficult to change.

Conclusion

Start at the start: establish the chemistry and determine what the consumable needs to manage the chemistry and clinical sample. Design your instrument based on the consumable needs. Have a clear strategy to control your core variables, such as temperature, time, concentration, pH and volume.

FMS’s role isn’t to tell every client to put the heater on the strip. It’s to understand what a client’s product actually needs and help them weigh the approaches and trade-offs against that.

That’s consistent with how we work more broadly, supporting clients from concept through to commercialisation and reducing the risk in that journey rather than adding to it.

Yes, acronyms and initialisms are rife here. But it is no wonder. We operate in a very complex, fast-moving environment, the learning curve is as steep as Mount Everest, and we are all both climbers and sherpas.

We communicate in intermittent gaps between multiple locations on site and in between a plethora of meetings: training, client updates, critical supplier talks, internal OKRs (objective key results, KPIs to most other businesses).

We do things a little differently here. It is a geek haven, a palace of nerd.

Our meeting rooms are named after our solar system’s moons, satellites to our main office. Our multiple labs, which allow us to isolate client projects and prevent information bleed-over, are named after sci-fi and sci-fact inspirations: The Portal Lab, Enigma, Tardis, Holodeck and the Dharma Initiative.

I am thankful to have been shepherded into this new role by a former work colleague. I came out of the most intense decade-long sprint as a founder of my own spin-out company. I had dedicated almost 15 years of my life to my non-living baby (an invention I am still convinced can change the world for the better). I sacrificed so much of my life to it that it took me over eight months to find myself again. I find myself once again protected from the crushing weight of being where the buck stops. Merely a support in the shield wall on the front line.

But it is very apparent I am needed here. My colleague, past and present, again looks tired; he has been through his own sprints. This business is a roller coaster just as brutal as my own venture was, but with more support and more security. It is packed with so much talent. It needs to be to meet the demands of what we choose to do. We work behind some massive names in the medical technology space. We have to meet the highest standards, every time, all the time.

For example, on day one I was presented with an introduction to our electronic quality management system (E-QMS, naturally). A crucial resource that enables us to trace EVERYTHING. Over 100 training assignments were allocated to me. Three months to complete them, but without doing the training, you can’t really do much of the jobs that need done. To be useful, I crank through hundreds of pages of SOPs, policies, work instructions and equipment-specific training. At least I have three monitors, so I can do the few useful things I am trained for as intermittent breaks to recover between document-reading sprints.

I am not the only new start; we have some awesome scientists joining at the same time too. We go to general induction training together. They’re cool, smart, nice people. I soon discover this is true almost universally here. The culture that has been ingrained here is one of support and collaboration: helping where you can, not being punished for asking for help, but encouraged instead. I like it.

Maybe things are too good to be true? What am I missing? We are hiring, that’s good, right? That means the company is growing, doing more business. I’ll keep my eyes peeled for any red or green flags just in case.

I think back to my first day. It just so happened to be on an all-hands monthly company update meeting day. There was a rather entertaining quiz to break up the more mundane updates and reporting on our OKRs. It was about tomatoes and potatoes; can you guess which variety name belongs to which vegetable? It was a deathmatch format. I think I did rather well, but not well enough to stay the distance (it lasted several minutes before we got down to sudden death, two players left). A green flag: gardening discussions welcome in the mix. I wonder if there is appetite from some people here to “make sports”.

Over many years, I have never stopped trying to stay on the healthier side of things, not to an extreme. I hate the gym, I dislike jogging. Too boring and repetitive. So, I found myself drawn to activities that are fun but are also good exercise: skating (all varieties), board sports (sun, sea, snow), cycling, racket sports, martial arts, etc. Something that keeps the mind focused while the body works in concert. The only real option amongst these for teamwork looks like racket sports. We are in Scotland, so if I want consistency, it should be indoors. Let’s go for badminton, less likely for injuries than squash.

So, I put it out there, an inquisitive mind seeking partnership out of the necessity of the game. To my surprise, there was a lot of interest, and even those not so convinced knew where to point the finger (Ali and Bhuvan were keen). And so, the internal group “Flexminton” was created. On Monday evenings, like clockwork, we now go five minutes’ drive from the office for an hour of fun exercise together. It is still growing its following, with almost 50% of the company now part of the group chat (though far fewer attend regularly).

Ok, three new starts, but what is this? Three people departing the company in the first month? Is this subtle evidence of a lurking red flag?

Naturally, I had to investigate.

One wanted to follow an engineering passion that needed more dedicated focus than the cut and thrust of subcontract development and manufacturing could offer. Another was taking early retirement which, when I thought about it, felt like a greener flag than many younger people might give it credit for. And the third was moving to another organisation in a similar space.

So I watched how it all went down.

Celebrations, notes of appreciation and personalised poems written and recited for all three. Plenty of well wishes and plans to stay connected. Nothing that suggested some hidden exodus, just three people moving on for three very different reasons.

It looks like my red flag chase was in vain.

Another five or so new starts join over the next couple of months. Each one an obvious expert in their field and each one fitting into this complex machine like sliding into tailored gloves. They clearly have a secret “Vibe” detector hidden somewhere that they use in the recruiting process. I wouldn’t be surprised, we have sensors for everything at FMS!

The company is growing, not just churning. I am relieved. It seems I have also slid into my position like pulling on gloves. Driver’s, not boxing. I release my concerns and enjoy the drive. I have a lot of work to do now that I am understanding the topology of the place.

I want to stay.

I can’t help but feel a touch of nervousness as I approach the hopeful end of my probationary period. This is a place of enablement, compatriots, exercise buddies, gardeners and more. We seem to celebrate something on an almost monthly basis. We had our company barbecue, a pizza party a couple of months earlier, and a breakfast roll (for all dietary requirements) is provided at every all-hands meeting too. We have unlimited access to Lavazza coffee (or some dangerously delicious hot chocolate) on our stalwart Gaggia office bean-to-cup machine.

I haven’t felt this looked after in a long time (thanks Mom BTW, love you). It has previously been me doing the looking after and, to be honest, they are doing a better job than I managed. I cross my fingers and get to work.

I’ve got a job to do, and I want to kick ass.

Customers arrive at FMS believing they’re closer to market than they are. A concept that works in the lab “most of the time” feels like enough to move into validation and manufacturing. It’s an understandable place to be – you’ve built something, it works, and the finish line looks close.

It usually isn’t. The FDA doesn’t grade on “most of the time.” For a device to be considered safe and effective, it has to work every time, and meet every claim every time it’s used. That standard sounds obvious written down, but it is more difficult to achieve than most system architects realize.

Why the gap is hard to see

The distance between “working” and “market-ready” is usually bigger than anyone wants to admit. Not because people are careless, but because it’s nearly impossible to judge the size of a problem while you’re still standing inside it. When a device is working ninety percent of the time, it feels like you’re nearly there. Then the law of diminishing returns arrives, and that last ten percent turns out to hold most of the effort.

The teams that make it to market tend to be the ones who find this out early, from someone other than the FDA. That’s most of what the work is: not building certainty, but locating the uncertainty while there’s still time and budget to do something about it. Designing a device that overperforms during development should safely meet specification during validation across multiple lots.

What that looks like in practice

Finding it early isn’t a single test or a gate you pass. For the clients we work with, it comes out of regular technical meetings, typically once a fortnight, that are about more than reviewing the latest data. We track where the project is heading overall, and where there’s a need, we give a view on regulatory risk: what we’d expect regulators to be looking for in a submission, measured against the client’s own intended-use statement. In some cases that extends to the device validation plan, and what we see there feeds back into development activity.

A concrete example. Say a client plans to let non-skilled operators use the device on-label. That triggers a CLIA-waiver requirement, which in turn means additional robustness has to be designed into the device and designed in early, because it’s validated later through flex testing. There’s no point running that testing if the robustness was never built in at the development stage. Catching that in a fortnightly review, rather than after a failed validation, is the difference between an adjustment and a rebuild. In cases like this, it’s also usually worth running a pre-submission with the FDA to be sure.

None of this is about slowing a project down. It’s the opposite: the earlier a readiness gap surfaces, the cheaper and simpler it is to close.

Why we work this way

FMS’s role isn’t to tell a customer their concept isn’t good enough. It’s to understand what the product actually needs to clear, and to hold that standard up against where the project currently is, honestly, and early enough to matter. That means sometimes being the ones to say the gap is wider than it looks. It’s a more useful thing to hear from a development partner than from a regulator.

Most concepts are further from ready than the person holding them believes. The ones that get to market are the ones who learn that in a technical meeting, not a rejection letter, and who have the time, when they learn it, to do something about it.

That’s consistent with how we work more broadly: supporting customers from concept through to commercialisation, and reducing the risk in that journey rather than adding to it.

As we celebrate this day in our calendar, we reflect on the experience of some of our female colleagues and why they were drawn to careers in science. Here’s what they had to say:

Eirini

I got into science because I love puzzles; the satisfaction when an idea clicks in my mind and then actually works in the lab! Since 2019, I’ve been designing assays and translating complex biochemical experiments into practical lab applications. I’m now an R&D Scientist at FMS, where I help turn diagnostic ideas into real-world products. It’s rewarding seeing my work become part of outputs that could directly impact patient testing and outcomes.

Mala

I’m a R&D Scientist at FlexMedical Solutions (FMS), with over 15 years’ experience in IVD development. I was drawn to science by curiosity and a care for others. Starting as a Product Support Investigator, I learned the importance of understanding real-world needs. Moving into R&D allowed me to turn ideas into products; seeing them reach patients is incredibly rewarding. At FMS, I’ve really valued the collaborative, cross-functional culture that supports growth and innovation. Being a scientist lets me ask questions and discover new things, and I want other girls to see that possibility for themselves.

Victoria

I am Quality Engineering Analyst at FMS with a background in forensic and analytical chemistry. I was drawn to science by curiosity and the opportunity to use problem-solving skills to make a real difference. At FMS, I’ve been able to grow my experience across R&D, Production, and Quality while contributing to the development of medical devices.

Kerry

I am a Senior R&D Scientist and Project Manager at FMS. I have spent four years working across a range of innovative projects. I’ve always loved science because it’s exciting, creative, and full of possibilities. My time at FMS has given me that chance to grow and lead meaningful work, whilst being part of a supportive team.

Sarah

Driven by curiosity and a passion for problem-solving, my journey in science took me from Animal Science into Bioengineering, where I completed a Master’s degree and PhD exploring stem cells as a novel approach to brain cancer treatment. Alongside my research, I set up a society to support women in engineering, while solo travel helped build resilience, independence, and a sense of adventure. I now work at FMS developing biosensors, applying my skills as a scientist within a meaningful, collaborative biotechnology environment.

Left to Right: Eirini, Mala, Victoria, Kerry, and Sarah

A key part of the visit was a presentation on Design for Manufacture (DfM) principles and methodologies. We explored how early design decisions influence cost, quality, and time to market, and how structured DfM approaches help de-risk development. Real project examples illustrated the value of considering materials, tolerances, automation, and supply chain realities from day one.

We’re proud to support the development of future engineers and to share practical insights from the frontline of medical device development. A big thank you to the Heriot-Watt team for collaborating with us, and to everyone who helped organise such an energetic and thoughtful visit. We look forward to seeing where these talented students make their mark in biotech engineering.

Artificial Skin: How Groundbreaking Research Inspires Innovative Solutions

The biochemistry landscape moves fast, and at FlexMedical Solutions we make a point of keeping pace with new developments that could shape the future of wearable diagnostics. One area that recently caught our eye was a fascinating advance from researchers at Aalto University and the University of Bayreuth, who created a self-healing hydrogel with properties similar to human skin.

Traditionally, hydrogels have offered either high stiffness or self-healing capability — achieving both at once has been a challenge. This new material successfully combines the two, overcoming long-standing limitations and opening the door to exciting applications including drug delivery, wound healing, soft robotics, next-generation sensors and artificial skin systems.

To achieve this, we designed and built a custom test jig capable of replicating a sweat-like effect underneath the wearable patch. This allows rapid, controlled testing of different fluidic designs.

The jig uses a perforated silicone sheet, created using a fine-gauge needle to mimic sweat pores. Once assembled with a dispersion plate and an inlet on the reverse side, the silicone can be gently pressurised with fluid. As pressure builds, droplets emerge through the perforations — much like perspiration through human skin. By connecting the jig to a programmable syringe pump, we can finely tune the flow rate to replicate the sweat levels expected during exercise.

This innovative setup enables us to iterate quickly, gather meaningful data and push our wearable lactate biosensor towards robust, real-world performance. It’s another example of how cross-disciplinary research continues to inspire practical solutions in medical device development.

At Flexmedical Solutions, we believe values aren’t just a set of words — they’re the foundation of how we operate, make decisions, and treat people.

In a fast-moving business environment, it’s easy to focus on growth, performance, and results. But sustainable success comes from something deeper — a shared understanding of why we do what we do and how we go about it.

Strong values give clarity when things get challenging. They provide a compass for decisions, guide behaviour, and create consistency across teams. Values also shape culture — they influence how people feel at work, how customers experience us, and how we build trust with partners.

For Flexmedical, our values are at the heart of everything. They reflect who we are, how we work together, and what our customers can expect from us.

Closing

Over the coming weeks, we’ll share the story behind our values, how they were developed, what they stand for, and the difference they’re making — both inside and outside the company.

Step 4 – Engineering a Stable Sensor Surface.

Developing a continuous lactate-measuring biosensor for a wearable device involves several biochemical and engineering challenges. A key requirement is stabilising the functionalised electrode surface so it can be successfully integrated into the wearable module.

To operate reliably on-body, the sensor surface must be dried in a stable state and protected by a selectively permeable membrane. This membrane plays a vital role:

• Protects the biochemical surface from contaminants in the sample
• Prevents user exposure to the surface chemistries
• Acts as an “analyte super-highway”, enabling efficient lactate diffusion to the electrode
• Allows soluble by-products of the biochemical reaction to diffuse away

We have now transferred the full functionalization process onto a bespoke electrode array designed for lactate measurement and additional functionality, including fill detection and a second working electrode for supplementary analytes such as pH.

Membrane Development and Early Testing

After multiple design iterations, we’ve established an insoluble, aqueous-permeable membrane that preserves biochemical activity and allows the sensor to be dried. This makes integration into the wearable fluidic module possible, ensuring controlled sweat delivery to the electrode and reliable waste removal.

Initial dry-state testing has delivered encouraging results. The example dataset demonstrates sensor behaviour over five repeated cycles at three lactate concentrations (0, 10 and 50 mM). Between each cycle, the sample is washed away and replaced with fresh solution.

Understanding Linearity and Calibration

We’ve also observed reduced linearity at higher lactate concentrations. This behaviour typically indicates that one element in the biochemical pathway is limiting the reaction rate. While raw current responses do not need to be perfectly linear, any non-linearity will translate into increased imprecision at high concentrations once the calibration algorithm is applied.
These findings are normal during biosensor optimisation and help shape our next steps: improving linearity while ensuring precision stays comfortably within commercial requirements.

What’s Next?

In our next update, we expect to demonstrate the complete system working together:

• On-body sweat collection
• In-situ biochemical detection and current generation
• Bluetooth communication to the mobile app
• Conversion to calibrated lactate concentration
• Continuous tracking over time

This is another strong step toward delivering high-performance continuous biosensing technology in a wearable format.