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.