Senior Hardware Systems Engineer
ONWARD Medical
About the job
The Senior Hardware System Engineer will perform hardware system design, integration, verification, and validation, converting customer requirements into product requirements and interface definitions. They will bring specialists together to solve difficult multi-disciplinary technical challenges. Working across all levels of system products, from concept, design, manufacturing, test, installation, operation, maintenance, they will play a leading role in developing our products.
Responsibilities
Design and shape the architecture of hardware solutions in collaboration with your colleagues in electronics, mechanical, thermal, biocompatibility, and biomedical modelling.
Lead risk management activities for hardware systems and new features.
Collaborate with engineers and peers from other disciplines (systems, software, mechanical, electronics, clinical) to develop and review technical solutions that implement user needs on the neuromodulation platform.
Drive quantitative feature development by performing tolerance analysis, error budget modelling, and statistical model-to-characterization matching.
Develop testing suites with a preference for automation and use throughout the full product development cycle, from concept development through to change regression testing.
Ensure traceability between requirements, design outputs, test cases, records, and reports.
Create, review, and execute verification and validation plans and protocols; own this process at the hardware system level and guide it at the hardware subsystem level.
Apply broad, in-depth clinical engineering and biomedical knowledge and adhere to the requirements of a regulated development and manufacturing environment.
Adhere to good laboratory practices; qualify and maintain tools and equipment.
Employ DRM (Design for Reliability and Manufacturing) tool sets when required, to include concept engineering, modeling and analysis, sensitivity studies, error budgets, stress analysis.
Overview of the full product lifecycle, including maintenance, service (warranty, support), configuration management, monitoring of installed systems.
Follow the change request process to constantly collect feedback and improve products
Perform other duties as requested