Senior Embedded Systems Engineer bei HistoSonics

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 (Onsite)

Travel: 10-20%

Position Summary:

The Senior Embedded systems Engineer is a highly technical, hands-on role for someone that leads technical root cause investigations and system characterization efforts for our advanced medical device capital equipment. This role is critical in ensuring robust integration of complex electromechanical systems with embedded software and firmware. The Senior Embedded Systems Engineer will work cross-functionally across engineering, quality, and manufacturing to resolve challenging system-level issues and improve product performance, reliability, and compliance.

 Key Responsibilities:

• Conduct detailed complaint analysis for hardware-software integration complaints and be the primary R&D contact for the complaint investigation.
• Lead structured root cause investigations for system-level issues across mechanical, electrical, firmware, and software domains.
• Design and execute experiments to characterize system behavior, confirm hypotheses, and isolate contributing factors.
• Develop and implement test methods and setups that replicate clinical conditions and edge-case scenarios. 
• Develop a deep understanding of the HistoSonics system, understand the interactions between all the subsystems and understand how the Edison software interacts which each of the subsystems. 
• Manage sustaining engineering projects related to changes and updates to commercialized product. This includes identifying and updating impacted product requirements, assessing related risk, writing test protocols, executing testing, analyzing data, writing reports, and drafting change orders to document and rationalize the impact to commercialized product(s).
• Analyze field data, error logs, and test results using tools such as Python, MATLAB, or LabVIEW to support investigations.
• Collaborate closely with cross-functional teams including R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs.
• Document findings in clear, structured formats suitable for design history files (DHF), CAPA, nonconformance investigations, and regulatory audits.
• Provide technical leadership and mentorship during integration phases of product development and V&V.
• Identify design improvements and risk mitigations based on investigation outcomes.
• Maintain awareness of relevant medical device standards (e.g., IEC 60601, ISO 14971) and design control requirements. 

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Systems Engineering, or a related discipline.
• 5+ years of experience in regulated industry or medical device development, ideally in embedded systems for capital equipment or complex systems integration.
• Demonstrated success in leading root cause investigations and performing system-level characterization.
• Expertise in hardware-software integration for medical device capital equipment
• Strong understanding of electromechanical systems with embedded software/firmware.
• Experience with tools such as oscilloscopes, logic analyzers, multimeters, and data analysis platforms (Python, MATLAB, LabVIEW, etc.).
• Solid knowledge of medical device regulatory frameworks, including ISO 13485, ISO 14971, and FDA QSR.
• Excellent communication skills—able to drive alignment, clearly document findings, and present to diverse technical and non-technical stakeholders.

 Preferred Qualifications:

• Experience working with Class II or III medical devices or systems governed by IEC 60601.
• Prior involvement in field issue investigations or post-market support for electromechanical systems.

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.

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