HistoSonics, Inc. · 9 hours ago
Principal Systems Engineer
Plymouth, MN, US
Full-time
Hybrid
Lead/Staff
$140K/yr - $165K/yr
8+ years expHistoSonics is a medical device company that has developed a non-invasive sonic beam therapy platform. The Principal Systems Engineer will lead the design, engineering, development, and testing of the company’s clinical systems, ensuring seamless integration of hardware and software components.
Health CareMedicalMedical Device
Responsibilities
Work within the product development lifecycle with a focus on requirements, traceability, and risk management
Work with SMEs in R&D on difficult root cause analysis for bugs discovered during testing or complaints coming from the field
Work with cross-functional teams (Product Development, Software Engineering, Operations, Regulatory, Quality, Marketing) to scope projects related to commercialized product changes and updates
Manage projects related to commercialized product changes and updates. This includes running project meetings, assigning tasks to team members, tracking deliverables, and driving projects to closure
Lead design-related efforts for projects related to cleared/approved commercialized products. 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)
Assist the engineering team with field reported issues. This may include evaluating product in the field and developing a plan to resolve any issues experienced by the customer. This will require working with the SMEs in R&D
Work with key stakeholders (cross-functional leadership) to determine appropriate priority of work related to commercialized product and product support, continuation, and service-related activities
Ensure that design documentation is in accordance with HistoSonics’ design control system (or external partner’s systems) and that all project deliverables are met
Work with cross-functional team to support, document, and track complaint handling
Work with the development team to develop field service training related technical materials that can be used to train future field service engineers who will provide support for the product
Champion improvements in systems engineering processes and tools
Qualification
Required
Bachelor's degree in engineering plus 8+ years related medical industry work experience
Experience in complex systems design, engineering, and product development (including product support during commercialization)
Experience driving products through development, verification and validation, resulting in successful regulatory submissions (globally)
Excellent communication skills and quality management systems experiences
Benefits
Health, dental, and vision insurance
Life, short-term and long-term disability insurance
401(k)
Paid time off
And more
Company
HistoSonics, Inc.
HistoSonics is a growth phase company developing a non-invasive sonic beam therapy platform and procedure using the science of histotripsy.
201-500 employees
H1B Sponsorship
HistoSonics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
$578.79MKey Investors
Alpha Wave VenturesSignature BankJohnson & Johnson Innovation
2025-10-16Private Equity· $250M
2025-08-07Private Equity
2025-08-07Acquired
Leadership Team
Mike Blue
President and CEO
Thomas Davison
Co-Founder - Advisor
Recent News
IEEE Spectrum
2026-01-03
2025-12-28
2025-12-24
Company data provided by crunchbase