Sr. Product 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

Position Summary (Why this role matters):

The Senior Product Engineer will work with the HistoSonics product team and external technical teams in the translation of user needs to product feature feasibility, definition, development and testing of the Company's globally regulated clinical systems and software. They will play an active leadership role in understanding product needs across various programs and initiatives, prioritizing and driving feasibility work of solution sets and leading a team with internal and external partners to develop prototype system and software features into marketable products. A key focus of this role is the design and development and integration of real-time diagnostic ultrasound capabilities, including partner ultrasound beamformers, transducers, and advanced imaging features and processing algorithms into HistoSonics' clinical histotripsy platforms.

Key Responsibilities (What you'll do):

• Manages external OEM partner feasibility and development work across various product/program needs, engaging in prioritization, technical direction, and definition of requirements and deliverables to meet project objectives.
• Drives internal product design definition and requirements for integration of OEM feature sets
• Works closely with the R&D management team and the cross-functional team to translate clinical needs into engineering requirements for feature feasibility and development work.
• Brings voice of the customer for features/functions as it is implemented and plays a critical role in bridging technical and commercial perspectives.
• Leads the timely design definition of new product features developed internally and by external partners, inclusive of software and system level requirements and test strategy. This may include electrical, mechanical, software and/or system integration related tasks.
• Understands how new functions/features fit into the overall technical roadmap, in alignment with the Program Director.
• Leads efficient and effective project engineering and management, including leading and/or contributing to feasibility plan/testing/reports, engineering requirements and specifications, cost estimation/analysis where applicable, design reviews, risk analysis, hazard analysis and FMEA-Design/Process/Use.
• Ensures that software and system design and development documentation is in accordance with Histosonics' design control system (or external partner's systems) and that all applicable project deliverables are completed (either internal or external).
• Leads the integration of real-time diagnostic ultrasound features, including but not limited to B-mode, color and power Doppler, and CEUS imaging, ensuring seamless integration into HistoSonics' clinical platform and alignment with applicable IEC 60601 and FDA guidance.
• Defines transducer and beamforming system requirements in collaboration with OEM ultrasound partners, driving technical specifications relevant to guidance and treatment monitoring applications.
• Collaborates with clinical and human factors teams to evaluate diagnostic ultrasound workflow usability, translating clinician feedback into actionable imaging feature requirements that improve procedural guidance, treatment monitoring, and patient outcomes.

Qualifications & Skills:

• Bachelor's degree in engineering.
• 5+ years of medical device product development experience.
• Experience in complex systems design, engineering and product development (including product support in clinical settings).
• Experience driving system level features through verification and validation, resulting in successful regulatory product submissions.
• Technical leadership (cross-functional) and partnership experience (with successful launches)
• Excellent communication skills and quality management systems experiences.

Preferred Qualifications and Skills:

• Diagnostic ultrasound system design and development experience, including hands-on work with ultrasound beamforming architectures, transducer characterization, image formation pipelines (B-mode, Doppler, harmonic imaging), and integration of ultrasound subsystems into complex, multi-modal medical devices.
• Experience in medical device software development process.
• Advanced image processing algorithm experience specifically with ultrasound and/or DICOM data sets
• Project management experience with external design partners.
• Knowledge of OEM ultrasound platform integration, including API-level software customization, scan sequence programming, and co-development of application-specific imaging protocols for clinical use.
• Experience with regulatory submissions for ultrasound-guided or ultrasound-integrated medical devices, including preparation of substantial equivalence arguments, bench test protocols, and supporting clinical evidence packages under FDA 510(k) or De Novo pathways.

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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