Principal Design 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 (Why this role matters):

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.

Key Responsibilities (What you’ll do):

• 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 through application of sound, 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.
• Participate in troubleshooting and risk assessment of issues with design teams to identify root cause and resolution.
• Supports as Subject Matter Expert (SME) during audits and inspections for risk management and non-product software validation processes. 

Qualifications and Skills: 

Required: 

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline. 
• 10+ years of progressive quality or design assurance engineering experience, including significant hands-on expertise in the development and commercialization of medical devices.
• Expert-level competency in the tools and processes used across the design control lifecycle, including requirements development and decomposition, traceability, risk management, verification and validation planning and execution, test method development and validation, statistical techniques and sampling rationale, design review leadership, and Design History File construction.
• Deep expertise in the medical device software/firmware development life cycle and software design assurance in accordance with IEC 62304, including software safety classification, SOUP management, software risk management, and software V&V.
• Experience operating within SAFe AGILE Framework or comparable agile frameworks and integrating design control deliverables into agile cadence.
• Deep understanding and applied knowledge of 21 CFR 820 / FDA QMSR, ISO 13485 and EU MDR, ISO 14971, IEC 60601 series, IEC 62304, IEC 62366.
• Strong analytical, critical thinking, and problem-solving skills with attention to detail and organizational goals.
• Ability to travel up to 10%, primarily within the United States, to support activities at HistoSonics offices, and/or clinical study sites. 

Preferred: 

• Deep expertise in the medical device software/firmware development life cycle and software design assurance in accordance with IEC 62304, including software safety classification, SOUP management, software risk management, and software V&V.
• Working understanding of electrical and mechanical engineering principles; preferably an understanding of ultrasound physics.

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.

U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position.

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