Sr. Windows Imaging and Validation Engineer

HISTOSONICS INC•Plymouth, MN

8d•$115,000 - $140,000•Onsite

About The Position

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. Position Summary: We are seeking a seasoned Senior Windows Imaging & Validation Engineer to take full ownership of our Windows imaging architecture and deployment infrastructure for life-critical medical device platforms. This is a senior individual contributor role requiring deep expertise in Windows Embedded operating systems, enterprise imaging toolchains, and system validation in a regulated medical device environment. You will serve as the subject matter expert (SME) on Windows imaging — setting standards, driving architecture decisions, mentoring junior engineers, and owning the full lifecycle from image build through validated deployment. If you have 5+ years deep in MDT, WDS, DISM, Windows PE, and Windows Embedded and want to apply that expertise in a mission-driven medtech company where your work directly supports life-saving patient outcomes, we want to hear from you.

Requirements

Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Information Technology, Biomedical Engineering, or a related field.
5+ years of hands-on experience building, maintaining, and deploying Windows PC images in an enterprise or regulated medical device environment (required).
Deep, demonstrable proficiency with Windows imaging and deployment tools: MDT, WDS, DISM, Windows PE, and/or SCCM (required).
Proven experience with Windows Embedded operating systems (e.g., Windows Embedded Standard, Windows 10 IoT Enterprise, or Windows IoT LTSC) in a regulated medical device or life sciences context (required).
Expert-level understanding of Windows OS architecture, configuration, and administration — including locked-down, hardened, and embedded configurations.
Demonstrated experience with Windows security hardening, patch management, BIOS/UEFI configuration, and driver integration in regulated environments.
Experience leading or mentoring other engineers on Windows imaging or deployment projects.
Familiarity with medical device regulatory standards (e.g., IEC 62304, ISO 14971, FDA 21 CFR Part 820) — direct experience preferred; we will support the right candidate in building regulatory depth.
Experience configuring and hardening Windows Embedded or Windows IoT LTSC platforms for regulated use cases.
Proficiency in PowerShell scripting for deployment automation and configuration management.
Familiarity with networked medical systems or interoperability standards (e.g., HL7, DICOM) and cybersecurity frameworks for medical devices.

Responsibilities

Own and architect the end-to-end Windows imaging strategy for medical device computing platforms, including Windows Embedded and Windows IoT LTSC configurations.
Build, configure, and maintain production-grade PC images for regulated medical device software hosting.
Design and implement automated image deployment pipelines using Windows-native tools (MDT, WDS, SCCM, Windows PE, DISM).
Establish image versioning standards, change control processes, and consistency across all hardware configurations.
Lead security hardening including patch management, driver integration, BIOS/UEFI configuration, and OS lockdown for regulated environments.
Serve as the Windows imaging SME across R&D, IT, manufacturing, and quality teams.
Mentor and guide junior engineers on Windows imaging best practices, deployment tooling, and regulatory documentation.
Lead technical reviews of imaging architectures, deployment plans, and validation protocols.
Collaborate with cross-functional stakeholders to define platform requirements and drive imaging strategy aligned with the product roadmap.
Lead evaluation and recommendation of hardware specifications for PCs used to host medical device software.
Assess and validate performance, compatibility, and reliability of computing platforms — including embedded hardware — under various operating conditions.
Integrate medical device software with validated Windows environments, including OTS hardware and software components (drivers, peripherals, and OS configurations).
Independently troubleshoot and resolve complex system-level issues related to Windows integration, embedded OS behavior, and platform performance.
Author and execute comprehensive V&V plans to validate Windows-based system configurations against product and regulatory requirements.
Conduct risk-based testing and document results per quality management systems (ISO 13485, FDA 21 CFR Part 820).
Support DHF contributions and regulatory submissions with traceable, audit-ready documentation.
Create and maintain senior-level technical documentation including imaging architecture specifications, deployment SOPs, test protocols, and validation reports.
Support regulatory submissions and audits, serving as a technical expert for imaging and platform-related inquiries.