Senior Systems Engineer

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.

Location: Plymouth, MN (Hybrid - Onsite 3 days a week)

Travel: 20%

Position Summary:

We are seeking a highly skilled Senior Systems Engineer to lead systems integration efforts for our cutting-edge Histotripsy platform. This role is pivotal in ensuring seamless integration of hardware and software subcomponents, maintaining system architecture, and supporting development and qualification of Non-Product Software (NPS) and development systems. The ideal candidate will bring deep expertise in embedded systems, medical device development, and cross-functional collaboration.

 Key Responsibilities:

 Systems Integration

• Lead the integration of subcomponents of the Histotripsy platform from an architecture, requirements, and testing perspective.
• Ensure optimal performance and reliability through coordinated integration of embedded hardware and software systems.
• Collaborate with design, software, and test teams to resolve integration issues and align on system-level goals.

Requirements Management

• Define, document, and manage subsystem and interface requirements using tools such as Azure DevOps, Jira.
• Ensure traceability and compliance with medical device standards (e.g., IEC 62304, ISO 13485).
• Conduct risk analysis and mitigation planning related to system integration.

Documentation & Reporting

• Develop and maintain comprehensive documentation of system architecture, integration workflows, test protocols, and results.
• Provide regular updates and technical reports to stakeholders and leadership.

Development System Support

• Support the development, maintenance, and qualification of NPS and internal development systems.
• Ensure development tools and environments are robust, validated, and aligned with regulatory expectations.

Testing & Validation

• Develop and execute system integration test plans to validate functionality, performance, and safety.
• Support verification and validation (V&V) activities in accordance with regulatory and quality standards.
• Analyze test results and drive resolution of defects and non-conformances.

Continuous Improvement

• Identify and implement improvements in systems engineering processes and tools.
• Promote best practices in systems integration and lifecycle management

Qualifications:

• Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or related field.
• 7 years of experience in systems engineering within the medical device industry or other regulated environments.
• Strong understanding of embedded systems, firmware/software integration, and hardware-software co-design.
• Experience with requirements management, V&V methodologies, and medical device lifecycle documentation.
• Familiarity with Histotripsy, ultrasound systems, or similar therapeutic technologies is a plus.
• Excellent analytical, organizational, and communication skills.
• Applicants must be authorized to work in the United States without the need for current or future sponsorship.
   

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-Hybrid