Systems Integration and Validation Engineer

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 (On-Site)

Position Summary:

We are seeking a technically skilled and detail-oriented Systems Integration & Validation Engineer to support the development and deployment of medical device software systems. This role focuses on evaluating and specifying PC platforms, integrating off-the-shelf (OTS) components, validating system performance, and managing PC image creation and deployment processes.

Key Responsibilities:

PC Platform Evaluation & Specification

• Analyze and recommend hardware specifications for PCs used to host medical device software.
• Evaluate performance, compatibility, and reliability of computing platforms under various operating conditions.

System Integration

• Integrate medical device software with OTS hardware and software components (e.g., drivers, operating systems, peripherals).
• Troubleshoot and resolve system-level issues related to integration and performance.

PC Image Management

• Create, configure, and modify PC images tailored for medical device software deployment.
• Maintain and update PC images with security patches, driver updates, and software revisions.
• Automate deployment of PC images using Windows-native platforms and tools.

Verification & Validation

• Develop and execute verification and validation (V&V) plans to ensure system compliance with product requirements and regulatory standards.
• Conduct risk-based testing and document results in accordance with quality management systems (e.g., ISO 13485, FDA 21 CFR Part 820).

Documentation & Compliance

• Create and maintain detailed technical documentation including system specifications, integration plans, test protocols, and validation reports.
• Support regulatory submissions and audits by providing clear and traceable documentation.

Minimum Qualifications:

• Bachelor's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related field.
• 3+ years of experience in systems engineering, integration, or validation within a regulated industry (medical devices preferred).
• Strong understanding of PC architecture, operating systems (Windows/Linux), and OTS software integration.
• Experience with Windows image creation, maintenance, deployment automation, and network deployment tools.
• Familiarity with medical device standards and regulatory requirements (e.g., IEC 62304, ISO 14971).
• Proficiency in test planning, execution, and defect tracking tools.
• Excellent communication and documentation skills.

Preferred Skills

• Experience with Windows-native imaging and deployment tools and methodologies (e.g., MDT, WDS, SCCM, Windows PE, DISM).
• Familiarity with cybersecurity considerations for medical devices.
• Experience with automated testing frameworks and scripting languages (e.g., PowerShell, Python).
• Knowledge of networked medical systems and interoperability standards (e.g., HL7, DICOM).

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.

#LI-Onsite