Principal Design Assurance Engineer

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Full Time Plymouth, MN, US

3 days ago Requisition

Salary Range: $ To $ Annually

Histo Sonics 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, Histo Sonics 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

Principal Design Assurance Engineer is an expert-level technical leader responsible for design assurance strategy and execution across the product portfolio. Working with a high degree of autonomy, they lead discussions with new product development teams to establish user needs and product design requirements through device concept and launch. This role has a particular emphasis on medical device software developed under IEC 62304, while retaining the flexibility to support hardware and system-level design assurance based on company needs.

• Lead partnerships with Regulatory, R&D, Engineers, and Product Developers in establishing product design requirements that are unambiguous, testable, and traceable to user needs and risk controls.
• Define the verification and validation strategy, including test method selection, acceptance criteria, statistical rationale, and sampling justification, and drive it to closure through protocols and reports.
• Partner with Software and Software Design Assurance teams across the software development life cycle, including software safety classification, software verification and validation, and software risk management in accordance with IEC 62304 and ISO 14971.
• Key member in design reviews to support Product Development Phase Closure and transfer to commercialization.
• 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 the review of product design documentation, specifications, and 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, the Quality Management System, and the non-product software and automated systems used in design, operations and manufacturing processes; identify and implement systemic improvements.
• Provide mentorship to engineers and product developers on compliance to applicable industry/regulatory product design/performance standards and lead activities to verify standards compliance.
• Participate as a key member in performing usability engineering activities including defining usability evaluation protocols.
• Participate as a key voice in new product development teams to influence design robustness, reliability, and safety…