Company Description
TACHMED is an early-stage medical device company developing connected in vitro diagnostic systems comprising biochemical assays, hardware instrumentation, and regulated software and algorithms. The company conducts in-house R&D and validation activities, with outsourced commercial manufacturing. We are seeking an experienced Solutions Architect to lead the design and evolution of complex, regulated software solutions for medical devices. This role is critical in bridging business needs, clinical requirements, and cutting-edge technology to deliver safe, effective, compliant, and innovative products that span embedded firmware, mobile/web applications, and cloud-based services. The ideal candidate brings deep cross-domain expertise in medical device development and a proven track record of architecting end-to-end systems under strict regulatory frameworks. A strategic thinker with medical device expertise and the ability to build compliant, high-impact solutions across the full technology stack.
Role Description
The Solution Architect will play a critical part in the design, development and commercialisation of the device working through from proof of concept to launch. The role is onsite with offices based in London. Reports to CEO/CPO.
Role Responsibilities
Lead the definition and documentation of end-to-end solution architectures for medical device products, including embedded systems, companion mobile/web apps, cloud backends, and connected ecosystems
Translate business, user, clinical, and regulatory requirements into high-level technical designs, system models, and architecture blueprints
Evaluate technology choices, trade-offs, and implementation strategies across firmware, mobile, web, and cloud domains to ensure scalability, security, reliability, performance, and maintainability
Ensure all architectures and development processes comply with medical device regulations and standards, including ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 62304 (Medical Device Software — Software Life Cycle Processes), and other relevant standards (e.g., MDR/IVDR, FDA guidance, IEC 60601 series where applicable)
Perform risk assessments, threat modelling, and hazard analysis as part of the architecture design process; integrate safety and cybersecurity by design principles
Collaborate closely with cross-functional teams including product management, clinical affairs, regulatory affairs, firmware/hardware engineers, software developers, DevOps, quality assurance, and external partners/suppliers.
Provide technical leadership and mentorship to development teams, guiding implementation to align with the defined architecture.
Design and oversee DevOps practices, CI/CD pipelines, automated testing, and deployment strategies suitable for regulated environments.
Contribute to technical roadmaps, feasibility studies, proof-of-concepts, and innovation initiatives while maintaining alignment with regulatory and business goals.
Communicate architectural decisions, risks, and rationales effectively to technical and non-technical stakeholders, including senior leadership and regulatory bodies.
Stay current with emerging technologies (e.g., Al/ML in healthcare, edge computing, IOT connectivity, cybersecurity trends) and assess their applicability to medical device solutions.
Key competencies
* Proven experience in full-stack software development across multiple domains:
* o Firmware for embedded systems (real-time OS, low-level programming, device drivers).
* o Mobile applications (iOS/Android) and/or web applications.
* o Cloud services and backend systems (e.g., AWS, Azure, GCP; microservices, APIs, data pipelines).
* Strong understanding of architecture patterns and best practices in each domain (e.g., layered/hexagonal architecture and Domain-Driven Design (DDD) in firmware and backend systems, MVVM Architecture in mobile, serverless/microservices/event-driven in cloud, REST/GraphQL/WebSockets).
* Hands-on experience implementing DevOps and CI/CD pipelines in regulated environments, with familiarity in tools such as Jenkins, GitHub Actions, GitLab Cl, Docker, Kubernetes, Terraform, Pulumi, and automated testing frameworks.
* Must have direct experience in medical device design, development, and lifecycle management (Class II/III devices preferred).
* In-depth knowledge of key medical device standards and processes:
* o ISO 13485 — Quality management for medical devices.
* o ISO 14971 — Application of risk management to medical devices.
* o IEC 62304 — Medical device software — software life cycle processes.
* o Familiarity with additional relevant regulations (e.g., EU MDR, FDA 21 CFR Part 820/11, cybersecurity guidance such as FDA Premarket Cybersecurity).
Skills
* Experience with modelling tools (e.g., UML/SysML, Enterprise Architect, Lucidchart, Draw.io) and documentation standards
* Experience with connected medical devices (IOT, BLE, MQTT, cloud-device integration)
* Knowledge of interoperability standards (e.g., HL7, FHIR, DICOM)
* Certifications such as AWS/Azure Solutions Architect, TOGAF, Certified SAFe
* Architect, or medical device-specific training
* Prior involvement in regulatory submissions or audits
* Proactive attitude and ability to self-manage
* Attention to detail
* Good communication skills (verbal and written)
* Excellent organisational skills
* Knowledge of Microsoft 365
Qualifications
* 10+ years of hands-on experience in software development and architecture.
* Bachelor's degree (or higher) in Computer Science, Electrical/Software Engineering, Biomedical Engineering, or a closely related field; equivalent extensive experience may be considered.