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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Systems Engineer - Embedded and Hardware - **Company:** Swiss Precision Diagnostics GmbH - **Location:** Cardington, UK (Remote available) - **Experience:** Expert - **Salary:** £60,000.0 - £70,000.0 - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Microsoft Windows, Systems Engineering, Microsoft Outlook, Configuration Management, Code Coverage, Embedded Software, Firmware, PC Tools, Microsoft PowerPoint, Software Engineering, Software Requirements Analysis, Verification and Validation (Software), Systems Architecture - **Published:** May 16, 2026 - **Apply:** https://find.jobs/jobs-near-me/systems-engineer-embedded-and-hardware-cardington-bedfordshire/2770902538-2/ ## About the Role * Proven experience in medical devices or IVDs, with hands on exposure to embedded electronics, firmware and software development within a regulated environment. * Bachelor s Degree in electrical engineering, software engineering or a related discipline; a Master s Degree would be advantageous. * Demonstrable experience overseeing third party design partners, OEMs and ODMs. * Strong background in real time embedded systems and instrument control. * Solid understanding of design controls, verification and validation. * Familiarity with statistical methods for V&V, measurement system analysis and design for reliability. * Highly organised with exceptional attention to detail. * Clear and confident communicator, both written and verbal. * Comfortable working within Microsoft 365; Outlook, Teams, Word, Excel, PowerPoint. * Strong sense of ownership and accountability. * Able to quickly interpret complex information and identify key technical and programme risks. ## Description We are seeking an experienced and Senior Systems Engineer Embedded and Hardware to take ownership of the electronics and software workstream for our IVD medical devices. This is a senior role where you will act as technical design authority, ensuring robust system architecture, supplier governance and regulatory compliance while working at system level rather than as a day to day coder. Based in Bedford and working closely with both in house teams and international third party suppliers, this role offers the opportunity to influence products from early architecture through regulatory approval and post market readiness. Reporting to the Head of Engineering, you will provide technical governance and leadership across hardware, embedded firmware and PC software, ensuring all development activities meet quality, safety and regulatory requirements. You will operate as the system-level technical owner, shaping architecture, design controls and verification strategies, while ensuring supplier outputs are delivered to the highest standards., * Third Party Oversight and Governance: Partner with external suppliers to develop electronics, embedded firmware, and software for an IVD medical device, leading supplier governance across design controls, KPIs, risk management, schedules, budgets, quality, and regulatory compliance. * Supplier Management and Deliverables: Author and manage supplier agreements (quality agreements, SOWs, acceptance criteria, configuration management) and review / approve all supplier outputs, including designs, code, risk documentation, testing artifacts, traceability, and release records * Design Controls and Technical Leadership: Own system and software requirements (including safety, EMI / ESD protection, and usability) and ensure full bidirectional traceability from user needs through design, verification, and validation. * Architecture, V&V, and Design Transfer: Lead system architecture decisions across electronics, firmware, and software; define and execute verification and validation strategies (including qualified tools and fixtures); and lead design transfer activities. * Regulatory Compliance and QMS: Ensure supplier activities operate under ISO 13485 compliant processes and deliver complete DHF / Technical Documentation regulatory expectations; align development to applicable standards. * Risk, Submission and Audit Support: Lead and document risk management (ISO 14971), ensure readiness for UDI, labelling, post market surveillance, and change control, and support regulatory submissions and notified body audits by presenting clear technical rationales and objective evidence. * Cross Functional and Stakeholder Integration: Integrate the electronics / software workstream with assay / chemistry, mechanical design, manufacturing / operations, and service, collaborating closely with Quality, Regulatory, Clinical, and Customer Support to ensure end to end readiness. * Risk, Performance and Delivery Management: Proactively identify and mitigate risks, manage non conformities and CAPAs with root cause analysis, and track / report KPIs including quality, schedule adherence, test coverage, and audit outcomes. * International travel required approximately 4 5 times per year. ## Related Videos - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Wolfenstein 3D Postmortem](https://www.wearedevelopers.com/videos/525-wolfenstein-3d-postmortem) - [Playing Pong on a shoulder press machine](https://www.wearedevelopers.com/videos/100140-playing-pong-on-a-shoulder-press-machine) - [Mutation Testing and Fuzzing in C#](https://www.wearedevelopers.com/videos/703-mutation-testing-and-fuzzing-in-c) - [WeAreDevelopers LIVE - Demo Time, Live Coding, End-to-End Testing and more](https://www.wearedevelopers.com/videos/1713-wearedevelopers-live-demo-time-live-coding-end-to-end-testing-and-more) - [Agent Smith Gets Hardware: Autonomous IoT Hacking From Debug Port to Cloud API](https://www.wearedevelopers.com/videos/100258-agent-smith-gets-hardware-autonomous-iot-hacking-from-debug-port-to-cloud-api) ## Related Articles - [Welcome to Switzerland](https://www.wearedevelopers.com/magazine/4-welcome-to-switzerland) - [Software Developer Salary in Switzerland [2023]](https://www.wearedevelopers.com/magazine/215-software-developer-salary-in-switzerland-2023) - [Is Switzerland Better Than Silicon Valley For Software Developers?](https://www.wearedevelopers.com/magazine/2-is-switzerland-better-than-silicon-valley-for-software-developers) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Top-Paying Tech Jobs (with Salaries)](https://www.wearedevelopers.com/magazine/372-top-paying-tech-jobs-with-salaries) - [The Ultimate Software Engineer Career Path Guide for 2023](https://www.wearedevelopers.com/magazine/146-the-ultimate-software-engineer-career-path-guide-for-2023)