Sr. Manager, Service Engineering

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 Manager, Service Engineering defines and advances the serviceability of HistoSonics products across both new product development and the commercial installed base. As the primary service engineering interface to R&D, the position ensures service requirements are established as formal design inputs and carried through to launch. The role owns the service technical documentation set, plans field upgrade and update campaigns, and serves as a senior technical escalation resource for field-reported issues. This is an individual contributor role with no direct reports at this time, accomplished through cross-functional collaboration and technical influence rather than direct authority. It does not include dispatch, scheduling, or day-to-day coordination of field service activity, which reside with Service Operations. As the installed base grows, the position is expected to build and lead a team of service engineers. Key Responsibilities (What You’ll Do) New Product Introduction Serve as the service engineering representative on R&D core teams, defining serviceability requirements as formal design inputs, including modularity, field-replaceable unit strategy, tool access, diagnostics, error codes, and system logs. Evaluate service concepts during development — mean time to repair, required technician skill level, on-site versus depot versus remote resolution, and total cost of service — and apply the analysis to inform design decisions. Establish service readiness criteria for launch and confirm documentation, tooling, training, spare parts, and diagnostics are complete prior to release; define and qualify service tooling, fixtures, and field test methods. Sustaining Engineering Improve serviceability of fielded products through analysis of field failure trends, service case data, and returned-unit findings, and implement approved design and documentation changes through the established change control process. Support failure modes and effects analysis, root cause investigation, corrective and preventive action, and engineering change orders with field data and technical assessment. Establish and report service performance metrics, including mean time to repair, first-time-fix rate, top failure modes, and upgrade completion rate, and define recommended spare parts lists and stocking levels. Technical Documentation and Field Upgrades Author, own, and maintain the service documentation set — service manuals, installation and preventive maintenance procedures, troubleshooting guides, field-replaceable unit replacement instructions, calibration procedures, and service bulletins — under the quality management system per 21 CFR Part 820 and ISO 13485. Lead technical planning and execution readiness for hardware upgrades, software and firmware updates, retrofits, and field actions, addressing scope and eligibility, configuration control, sequencing, kits and spare parts, downtime estimates, and contingency provisions. Author and verify upgrade instructions and post-upgrade verification protocols, and coordinate with Quality and Regulatory on the appropriate change control, validation, and notification pathway for each field change. Technical Escalation and Advisory Serve as a senior technical escalation resource for issues front-line field service and technical support cannot resolve, troubleshooting to root cause using system logs, error codes, drawings, and returned hardware. Determine whether escalated issues reflect isolated events, documentation or training gaps, or design deficiencies, and elevate potential complaints and reportable events to Quality and Regulatory within required timeframes. Serve as technical subject matter expert to the Training function, which retains ownership for curriculum development and delivery; define training requirements and competency criteria and review materials for technical accuracy. Advise commercial, clinical, and Service Operations teams on serviceability, field changes, and system configuration, communicating complex technical information clearly to non-technical audiences. Qualifications and Skills Bachelor's degree in Mechanical, Electrical, Biomedical, or Systems Engineering, or a related technical discipline, or an equivalent combination of education and directly related experience. 8+ years of experience in service engineering, sustaining engineering, product support, or field service engineering supporting complex electromechanical or capital equipment. 5+ years defining serviceability or service requirements for products in development through launch, with experience in both sustaining engineering and new product introduction. Demonstrated experience authoring technical service documentation under document control, and planning and executing field upgrades, updates, or field corrective actions across an installed base. Strong troubleshooting capability across mechanical, electrical, and software domains, with the ability to interpret mechanical drawings and GD&T, electrical schematics, and wiring diagrams. Excellent written and verbal communication skills, with a demonstrated ability to translate complex technical concepts into clear, accessible explanations for non-technical and mixed audiences. Experience within a regulated quality system (21 CFR Part 820, ISO 13485, design controls, change control, complaint handling), and demonstrated ability to influence outcomes across functions without direct authority. Preferred Capital medical device experience for hospital, interventional, or surgical environments, including surgical robotics or therapeutic ultrasound. Experience establishing or scaling a service engineering function at an early-stage or high-growth company. Familiarity with remote diagnostics and log analysis, and with PLM or service management platforms (Arena, Windchill, Salesforce Field Service). Travel and Work Environment Travel up to 20%, domestic and occasional international; valid driver's license required. Work spans office, laboratory, and customer site environments; requires handling of systems returned from clinical use per decontamination, ESD, and bloodborne pathogen protocols, ability to lift up to 50 pounds, and schedule flexibility across time zones. 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. U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position. #J-18808-Ljbffr