HistoSonics, Inc. · 1 month ago
Senior Design Assurance Engineer
Plymouth, MN, US
Full-time
Hybrid
Senior Level
$110K/yr - $130K/yr
5+ years expHistoSonics is a medical device company focused on advancing the science of histotripsy for treating liver tumors. The Senior Design Assurance Engineer will support design assurance activities, work with product development teams, and ensure compliance with design requirements and regulatory standards.
Health CareMedicalMedical Device
Responsibilities
Work with Regulatory, R&D, Engineers, and Product Developers in defining product design requirements and verification/validation methodology and acceptance criteria
Work with Product Developers to ensure system architecture and testability of products is maintained
Supports adherence to Design Controls throughout product lifecycle
Support for product safety risk management (human factors, HW/SW design, process); identifies and implements systemic improvements and supports post-production risk management activities
Provide technical expertise in review of product design documentation and specifications
Support Design Reviews
Review design history files to assure technical accuracy, completeness and compliance with applicable internal, regulatory and customer requirements
Provide guidance to continuously improve design and development processes
Provide guidance to engineers and product developers on compliance to applicable industry/regulatory product design/performance standards and lead activities to verify standards compliance
Support for non-product software and automated systems used in design, operations and manufacturing processes; identifies and implements systemic improvements
Assist in performing usability engineering activities including defining usability evaluation protocols
Participate as a member of new product development teams to influence design robustness, reliability, and safety through application of sounds, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving/preventing design quality issues
Provide input into inspection strategy and plans including working with suppliers on purchased product requirements and development of measurement methodologies
Support the transfer of specifications and processes to production during design transfer phase
Assist in developing design verification and validation plans, protocols and reports
Participate in troubleshooting and risk assessment of issues with design team to identify root cause and resolution
Supports Subject Matter Experts (SME’s) during audits and inspections for risk management and non-product software validation processes
Participate in continuous improvement of the Quality Management System
Maintain safe and clean work environment
Other duties as assigned by the Director of Product Assurance
Qualification
Required
Bachelor's degree required
5+ years of quality engineering experience in a Manufacturing environment, preferably in a medical device
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Strong analytical, critical thinking, and problem-solving skills with an attention to detail and organizational goals
Basic understanding of electrical and mechanical engineering principles and ultrasound physics
Experience with verification and validation testing, risk management, design control, and Quality Management Systems
Experience with medical device software development life cycle
Experience with FDA Quality System Regulations, ISO 13485 and EU MDR, ISO 14971, IEC 60601 series, IEC 62304, IEC 62366
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