HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.
We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.
Location: Plymouth, MN, Ann Arbor, MI or Madison, WI (Onsite)
Travel: 15%
Position Summary (Why this role matters):
We are seeking a Linux Image Engineer to design, build, and maintain secure, minimal Linux environments that power the connectivity subsystem for our medical devices. This subsystem acts as a secure gateway between on-premise equipment and cloud services, ensuring reliable and compliant data exchange within hospital networks. This role owns the full lifecycle of embedded Linux images, including development, hardening, validation, compliance documentation, and deployment in regulated environments.
Key Responsibilities (What you’ll do):
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Design and maintain minimal, hardened Linux images for embedded systems (ARM64, NVIDIA Jetson).
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Build images using Yocto, Ubuntu, or similar frameworks.
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Configure kernel, drivers, and system services.
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Optimize system performance and reduce attack surface.
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Implement security controls (secure boot, TPM, encryption, access controls)
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Develop CI/CD pipelines and automated validation testing.
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Generate SBOMs, track and manage vulnerabilities (CVE remediation).
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Author, own and support regulatory compliance (FDA, IEC standards) and build process documentation.
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Enable secure OTA updates and field deployments.
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Collaborate with cross-functional engineering and regulatory teams.
Qualifications and Skills:
Required:
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Bachelor's degree in Engineering, Computer Science, Software Engineering, or a related technical field preferred.
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3+ years of experience in the medical device industry in a software, systems, cybersecurity, or related technical role.
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Strong understanding of Linux operating system internals, including kernel architecture, boot processes, device drivers, and networking.
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Hands-on experience developing and maintaining embedded Linux platforms using tools such as Yocto, Buildroot, or similar frameworks.
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Demonstrated expertise in system hardening, vulnerability management, and cybersecurity best practices for embedded or connected systems.
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Experience designing and supporting CI/CD pipelines, automated testing frameworks, and software quality assurance processes.
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Familiarity with regulated development environments (FDA, IEC 62304, ISO 13485, IEC 81001-5-1, etc.) or a strong willingness to learn and adapt to regulatory requirements.
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Strong technical documentation, requirements management, and traceability skills, with the ability to maintain clear and audit-ready design records.
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Excellent analytical, troubleshooting, and problem-solving skills with attention to detail.
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Strong communication and cross-functional collaboration skills, with the ability to effectively work across engineering, quality, regulatory, and product development teams.
Preferred:
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Ubuntu
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NVIDIA Jetson experience.
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HL7, FHIR, or DICOM knowledge.
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Cloud IoT experience (Azure, AWS).
Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position.
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