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Principal Digital Hardware Engineer

1 month ago

United Kingdom Halian Technology Limited Full time

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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