Job Description
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 (On-Site)
Position Summary (Why this role matters):
The Software Manager, Testing is responsible for leading a team of software test engineers and managing all test efforts during the software development process to ensure HistoSonics’ software quality. The Software Manager, Testing will participate in design reviews, risk analysis, lead software defect risk assessments, and track software quality metrics. This position will monitor all stages of software development to identify and resolve software malfunctions to meet quality standards.
Key Responsibilities (What you’ll do):
- Interact with product development teams to develop a strong understanding of the project and testing objectives
- Partner with design and software teams to define requirements and architecture that ensure software testability
- Estimate, prioritize, plan and manage testing activities
- Lead a team of software test engineers to assess, plan, and manage project resources while developing test plans and test cases based on requirements
- Manage development and execution of automated and unit tests/plans and analysis and reporting of test results
- Lead design reviews and risk assessment meetings
- Manage setup of test environment (hardware, software and network)
- Manage testing of software releases (manual and/or automated)
- Track and manage defects through defect tracking system
- Track and monitor changes of off-the-shelf components used by software
- Lead analysis to determine scope of regression testing when defects are resolved
- Track software quality assurance metrics, like defect densities and open defect counts
- Training/leading/mentoring software test engineers
- Ensure all applicable tasks are performed in compliance with the Quality Management System
- Participate in continuous improvement of the Quality System, software development and testing procedures
Qualifications and Skills:
- Bachelor’s degree in a Computer Science, Math, or Engineering or related field
- 8+ years of software testing experience
- 2+ years of experience managing people
- Experience with FDA regulations and medical device quality systems (e.g., 21 CFR Part 820)
- Experience across the product development lifecycle
- Experience with automated test frameworks
- Understanding of electrical and mechanical engineering principles
- Proficiency with operating systems, especially Microsoft Windows
- Experience with databases (e.g., Microsoft SQL Server)
- Experience with performance and stress testing tools
- Experience with source code control and defect tracking systems
- Strong prioritization skills across multiple tasks/projects
- Detail-oriented with strong analytical skills
- Team-oriented and self-motivated, with the ability to learn quickly and build effective cross-functional relationships
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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