Sr. Manager – AI and R&D Infrastructure

HISTOSONICS•Plymouth, MN

1d•Hybrid

About The Position

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 Sr. Manager, AI and R&D Infrastructure leads the team responsible for cloud platforms, AI automation, and systems imaging capabilities across the CTO organization. This role ensures the reliability, security, compliance, and continuous evolution of critical infrastructure and tools that support software development, research, clinical operations, and product innovation. The position partners closely with technical and business leaders to execute strategy, develop talent, drive operational excellence, and foster a culture of engineering excellence, accountability, and continuous improvement.

Requirements

Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field; advanced degree is a plus
10+ years of progressive experience in IT platform engineering, DevOps, infrastructure engineering, or related disciplines
4 years in a people leadership role managing technical teams of 5 or more engineers; demonstrated track record of building and scaling high-performing teams
Proven experience operating at a senior manager level, including contributing to team strategy, managing organizational structure, and influencing technical direction across a broader organization
Advanced knowledge of Azure cloud infrastructure and architecture; sufficient depth to provide technical direction, evaluate significant architectural decisions, and hold the team to high engineering standards across cloud platform, observability, CI/CD, IaC, and containerization domains.
Working knowledge of AWS is a plus.
Experience with agentic AI concepts, LLM application patterns, and AI governance considerations; able to help shape direction for AI automation work, evaluate the team’s technical approach, and engage credibly with AI-related decisions
Working knowledge of Windows and Linux systems imaging, endpoint management, platform security practices, and hybrid cloud connectivity; sufficient to provide direction and evaluate team execution
Experience operating in a regulated environment (FDA, ISO 13485, IEC 62304, HIPAA, SOC 2); familiarity with computer systems validation (CSV) and 21 CFR Part 11 is strongly preferred; awareness of medical device cybersecurity frameworks including NIST and FDA guidance
Strong organizational influence: builds effective cross-functional partnerships, advocates credibly for the team’s priorities, navigates competing demands with sound judgment, and contributes meaningfully to broader CTO organization leadership discussions
Operates with meaningful autonomy and a bias toward action; comfortable holding ambiguity while driving clarity for the team; maintains a forward-thinking mindset and keen awareness of the downstream impact of organizational and technical decisions

Nice To Haves

advanced degree is a plus
Working knowledge of AWS is a plus.
familiarity with computer systems validation (CSV) and 21 CFR Part 11 is strongly preferred

Responsibilities

Provide leadership to a team of cloud platform engineers, agentic AI developers, and systems imaging specialists; establish a high-performance team culture grounded in engineering excellence, security by design, continuous learning, and clear accountability for outcomes
Attract, hire, develop, and retain top technical talent; actively shape the team’s organizational structure, role definitions, and career pathways to build durable capability aligned with HistoSonics’ long-term technical strategy
Contribute to and execute the AI and R&D Infrastructure team’s strategy and multi-quarter roadmap in partnership with the Sr. Director; translate the CTO organization’s technical and business objectives into a coherent set of product cloud platform, AI automation, and infrastructure investments that deliver measurable value
Operate with autonomy in setting day-to-day priorities; make informed recommendations about where the team’s time and resources are best invested, balancing immediate operational needs against strategic capability-building; communicate the rationale for these decisions clearly to stakeholders at all levels
Represent the AI and R&D Infrastructure team in Product Development organization planning, architecture forums, and cross-functional leadership discussions; advocate effectively for the team’s priorities, surface emerging risks and opportunities, and influence decisions that affect the broader CTO organization
Establish the team as a trusted, proactive partner across the organization by building and maintaining strong partnerships with the Sr. Director – Software Platforms and Technology Strategy, software engineering leadership, Information Systems, Security, Data Privacy, Quality, and Regulatory stakeholders.
In partnership with Information Systems and Security, establish and evolve product cloud infrastructure governance: policy-driven controls, reusable IaC templates and modules with best practices embedded, enforceable guardrails, and organizational standards for cost tracking, naming, tagging, alerting, logging, and observability; hold the team accountable for consistent application of these standards
Partner with Information Systems leaders for cloud resource hierarchy, subscription management, and management group governance at the highest organizational level; ensure compliance and security requirements for cloud infrastructure are tracked, communicated, and addressed
Guide the team in evaluating and adopting new cloud tools, architecture patterns, and platform capabilities; champion a culture of continuous improvement and deliberate technical evolution
Guide the team in maintaining Infrastructure as Code practices, reusable module libraries, and environment management strategies; ensure IaC standards are documented, governed, and accessible across the CTO organization
Drive the direction for agentic AI and automation capabilities across HistoSonics’ CTO org, clinical, Quality and operational domains, in partnership with the Sr. Director; identify high-value automation opportunities in partnership with CTO organization leadership and translate them into a prioritized delivery roadmap
Partner with Product and Information Systems Security to ensure the team builds agentic systems with rigorous governance, including appropriate guardrails, observability, human-in-the-loop controls, responsible use standards, and AI-specific risk analysis appropriate for a regulated medical device environment
Stay current on the evolving agentic AI landscape; evaluate emerging frameworks, foundation models, and AI platform capabilities; guide the team in adopting practices and tooling that advance HistoSonics’ AI automation maturity responsibly
Own the execution and contribute to the evolving strategy for Windows and Linux systems imaging, endpoint management, and configuration management across product computing systems; ensure the team’s practices meet the needs of both corporate and regulated R&D and laboratory use cases
Ensure product endpoint security standards, patch management processes, secrets managment, and configuration baselines are maintained in alignment with HistoSonics’ Information Systems security policies, best practices, and applicable regulatory requirements; maintain a strong working relationship with Information Systems leadership on endpoint compliance
Ensure all team activities comply with HistoSonics’ Quality Management System and applicable regulatory requirements including IEC 62304, FDA 21 CFR Part 820, ISO 13485, HIPAA, and SOC 2; oversee computer systems validation (CSV) activities for GxP-relevant infrastructure and validated computing environments managed by the team
Participate in architecture reviews, threat modeling, and change control processes as a senior representative of the AI and R&D Infrastructure function; ensure the team’s work is well-documented and that workflows, standards, and modules are accessible and understandable across the CTO organization
Own escalation and resolution of high-impact product development infrastructure incidents, pipeline failures, agent defects, and imaging issues; drive root cause analysis and ensure effective corrective actions that prevent recurrence
Other duties as assigned by the Sr. Director – Software Platforms and Technology Strategy