HistoSonics, Inc. · 3 months ago
Senior Quality Engineer (Senior Product Assurance Engineer)
Plymouth, MN, US
Full-time
Onsite
Senior Level
$110K/yr - $120K/yr
5+ years expHistoSonics, Inc. is a medical device company that has developed a non-invasive sonic beam therapy platform. The Senior Product Assurance Engineer will lead product assurance activities for commercial production support, including inspection, product release, and nonconforming material handling.
Health CareMedicalMedical Device
Responsibilities
Leads process FMEA (PFMEA) development and ongoing updates
Leads product inspection strategy and planning including working with suppliers on purchased product requirements and development of measurement methodologies
Supports supplier evaluation, auditing, and performance monitoring
Supports development of in-process and final product testing
Supports design assurance engineering as needed with risk management activities and review of design documentation including product design requirements and design verification test protocols
Collaborates with design assurance and manufacturing engineering to ensure that procedures, practices, and documentation comply with applicable standards and regulations
Supports the transfer of specifications and processes to production during the design transfer phase
Supports equipment control and process validations
Reviews Device History Records (DHR) and completes product release
Leads nonconforming material review and documentation
Uses knowledge of statistics to support inspection, testing, and process validation activities
Performs product complaint analysis including associated risk management file reviews and updates
Acts as Subject Matter Expert (SME) during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis
Develops, modifies, and maintains quality system procedures, work instructions, and forms
Support internal and external audit activities as needed
Lead CAPA investigations, action planning, and follow-up for assigned CAPAs
Maintains a safe and clean work environment
Other duties as assigned by the Director of Product Assurance
Qualification
Required
Advanced degree in a Computer Science, Math, or Engineering related field and 3 years of relevant experience in the medical device field, or Bachelor's degree and a minimum of 5 years of relevant experience
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes, and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Experience with risk management, nonconforming material, and complaint handling systems
Experience with practical application of statistics for product inspection and testing
Experience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971
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