Systems Engineer - Embedded and Hardware in Cardington

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.

Key Responsibilities:

• 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.

We’re Looking for Someone Who Has:

• 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.

We Can Offer You:

• An excellent working environment.
• Hybrid working – three days a week in the office with two days a week working from home.
• 25 days paid annual leave plus bank holidays.
• Company pension scheme including competitive employer’s contribution.
• Private Medical Insurance package with additional medical cash plan scheme.
• Enhanced maternity and paternity pay.
• Company supported employee Health and Wellbeing programme.
• Life assurance.
• Free plentiful car parking and electrical car charging points.
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London.

The Company: Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products. Our SPD research centre is at the cutting edge of innovation and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.

Interested? Click apply and you will be redirected to our careers page to complete your application.