Salary: £60,000 - 70,000 per year Requirements: Proven experience in medical devices or IVDs, with hands-on exposure to embedded electronics, firmware, and software development in a regulated environment. Bachelors degree in electrical engineering, software engineering, or a related discipline; a Masters 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 verification and validation, 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, including Outlook, Teams, Word, Excel, and PowerPoint. Strong sense of ownership and accountability. Able to quickly interpret complex information and identify key technical and programme risks. Responsibilities: Take ownership of the electronics and software workstream for our IVD medical devices. Act as technical design authority, ensuring robust system architecture, supplier governance, and regulatory compliance. Partner with external suppliers to develop electronics, embedded firmware, and software for an IVD medical device. Lead supplier governance across design controls, KPIs, risk management, schedules, budgets, quality, and regulatory compliance. Author and manage supplier agreements, including quality agreements, statements of work, acceptance criteria, and configuration management. Review and approve supplier outputs, including designs, code, risk documentation, testing artifacts, traceability, and release records. Own system and software requirements, including safety, EMI/ESD protection, and usability. Ensure full bidirectional traceability from user needs through design, verification, and validation. Lead system architecture decisions across electronics, firmware, and software. Define and execute verification and validation strategies, including qualified tools and fixtures. Lead design transfer activities. Ensure supplier activities operate under ISO 13485-compliant processes and deliver complete DHF and technical documentation. Align development to applicable standards. Lead and document risk management in line with ISO 14971. Ensure readiness for UDI, labelling, post-market surveillance, and change control. Support regulatory submissions and notified body audits by presenting clear technical rationales and objective evidence. Integrate the electronics and software workstream with assay/chemistry, mechanical design, manufacturing/operations, and service. Collaborate closely with Quality, Regulatory, Clinical, and Customer Support to ensure end-to-end readiness. Proactively identify and mitigate risks. Manage non-conformities and CAPAs with root cause analysis. Track and report KPIs, including quality, schedule adherence, test coverage, and audit outcomes. Travel internationally approximately 4 to 5 times per year. Technologies: Embedded Excel Firmware Support Marketing Microsoft 365 Office 365 Flow Hardware More: We are Swiss Precision Diagnostics GmbH (SPD), a world leader in the research, design, and marketing of advanced consumer diagnostic products. Our research centre is at the cutting edge of innovation and is fully engaged in developing reliable diagnostic products that empower women on their reproductive journey. This is a senior, Bedford-based role with hybrid working, offering three days in the office and two days working from home. We offer an excellent working environment, 25 days paid annual leave plus bank holidays, a company pension with competitive employer contribution, private medical insurance with an additional medical cash plan, enhanced maternity and paternity pay, a health and wellbeing programme, life assurance, free parking, electrical car charging points, and a beautiful parkland setting with excellent transport links to Cambridge, Milton Keynes, and London. last updated 20 week of 2026