Senior Design Quality Assurance Engineer

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

The Sr. Design Quality Assurance Engineer will support design assurance activities and initiatives supporting Product Development projects including establishing and improving product design requirements, design review activities, risk management and the development of testing requirements. This role will work with new product development teams to assess product designs as well as working with the team on establishing product design requirements and a strategy for evaluating and demonstrating conformance to the requirements.

Key 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

Qualifications And Skills

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 : 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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