Principal Hardware Engineer

This is a fantastic opportunity for an experienced Senior or Principal Hardware Engineer with strong skills in the design and delivery of complex circuits to join a growing Medical Device business at an exciting phase of development as they expand the team and accelerate towards its first Pivotal Trial.

You will be part of a ground-breaking team based in a custom-built facility in Oxfordshire, creating life-changing therapies for millions of people globally. The position offers benefits including; a competitive salary, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays).

Key Responsibilities:

• Lead the design and development of complex electronic circuits (analogue, digital, and mixed-signal systems) for medical devices.
• Oversee PCB design and layout, ensuring signal integrity, power management, and manufacturability & evaluate and select components.
• Drive the integration of hardware with software and mechanical components to develop fully functional systems.
• Collaborate with cross-functional teams to deliver innovative solutions.
• Conduct detailed root cause analysis and resolve system-level challenges.
• Define and execute rigorous validation and verification plans to meet regulatory and performance standards, such as ISO 13485 and IEC 60601.
• Develop test fixtures and automate testing processes to ensure efficiency and accuracy.
• Work closely with Process Engineering and Production teams to ensure designs are manufacturable and scalable, resolving design-related challenges to enable smooth transition from development to production.
• Provide technical leadership to the hardware engineering team & mentor junior engineers.
• Contribute to technical reviews and decision-making processes, ensuring adherence to best practices.
• Generate comprehensive technical documentation, including schematics, test plans, and design reports, for internal and regulatory purposes.
• Present design concepts and progress updates to stakeholders, including senior leadership and external partners.
• Research and implement emerging technologies to enhance device functionality and performance & identify opportunities for process improvement in workflows.

Skills & Experience

• Degree in electronic or biomedical engineering, or a related field
• Demonstrable experience in hardware design, development, and testing, preferably in the medical device industry (or otherwise an equivalent highly regulated industry)
• Proven track record of designing and delivering complex analogue, digital, and mixed-signal circuits.
• Experience with PCB design tools (e.g. Proteus, Altium Designer or CAD) and simulation tools e.g. SPICE, MATLAB).
• Strong understanding of signal processing, power management, and embedded systems.
• In-depth knowledge of medical device regulatory standards (ISO 13485, IEC 60601) and design controls.
• Experience in system-level integration, debugging, and troubleshooting.
• Familiarity with programming languages such as Python, C/C++, and tools for test automation.
• Experience in active implantable devices is highly desirable.

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