Sr. 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:

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. 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

• 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 software design assurance 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.
• 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 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.
• 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.
• Strong experience with the medical device software/firmware development life cycle and software design assurance in accordance with IEC 62304.
• Familiarity with SAFe AGILE Framework for software development cycle.
• 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 attention to detail and organizational goals.
• Basic understanding of electrical and mechanical engineering principles; preferably an understanding of ultrasound physics.
• Experience with verification and validation testing, risk management, design control, and Quality Management Systems.
• 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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