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

About you

• Master's or PhD degree in engineering or physics (e.g., electrical or micro-technical); Biomedical and Clinical engineering experience is a plus.

• 7 + years relevant industry experience, preferably active implantable medical devices

• System engineering background, preferably with a focus on neuromodulation

• Strong understanding of applicable regulations including ISO, FDA, GMP, and design controls

• Good understanding of statistical methods relevant to tolerance/confidence intervals, product and process capability, process control and the evaluation of acceptance criteria for design characterization and verification

• Expertise in scripting languages such as Python

• A team player who can collaborate well with other engineers with varying levels of experience and provide guidance to the team.

• Comfortable with ambiguity in the early phases of development, discussion, and resolution of system-level trade-offs to ensure rapid product discovery and development

• Results-oriented, hands-on, and thrives in an innovative, fast-paced, and performance-driven organization.

• Ability to work in a matrixed and geographically diverse business environment.

Supervision

Individual contributor reporting to the Director Hardware Engineering.