Quality Engineer

About iSono Health Inc.

iSono Health is a dynamic and rapidly growing early clinical-commercial stage medical device company dedicated to saving lives and transforming care through innovative robotics, AI, and 3D ultrasound technologies. 

At iSono Health, we're pioneering a new era of breast care. We believe every woman deserves access to fast, affordable, and comfortable screenings. That's why we developed ATUSA, the world's first AI-powered platform with a point-of-care, automated 3D ultrasound system.

To succeed here, you need to think like an entrepreneur, act like a leader, and execute with precision. We value individuals who take initiative, embrace challenges, and are excited to wear multiple hats. Creativity, resilience, and a commitment to excellence are essential as we push the boundaries of what’s possible in healthcare.

Our work is exciting because it’s meaningful. Together, we’re empowering women to take control of their health by expanding access to potentially lifesaving ultrasound technology. If you’re passionate about making a difference and ready to be part of a nimble, scrappy team that values impact over hierarchy, iSono Health is the place for you.

At iSono Health, success isn’t just about the work—it’s about the mindset. We’re a small but mighty team of dedicated individuals driven by a shared mission: revolutionizing women’s health and making a profound impact for patients and clinicians. With big ambitions and innovative plans, we thrive in a fast-paced, dynamic environment where every team member owns what they build.

Join us in transforming healthcare and be part of a team where every voice matters, every idea counts, and every action contributes to a greater purpose.

About the role

iSono Health is looking for a Quality Engineer to help us drive our quality mission by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve products and processes.

Job Responsibilities

• Support company product development and design changes activities in compliance with the company's Quality System, focusing on DFX, and assess the reliability of new designs.
• Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, Design Transfer, etc.
• Serve as project management lead with compliance to Design, Process, and Purchasing Controls and Risk Management procedures and delivery of robust Design History Files.
• Support manufacturing and operation activities including performing inspections, production quality assessment, and finished goods fulfillment 
• Participate in design impact assessments and supplier quality management 
• Plan and create quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices utilizing clinical and engineering knowledge.
• Develop comprehensive procedures, including work instructions, flowcharts, forms, templates, checklists, and other product or process-related documentation, for recording, evaluating, and reporting product and process quality data.
• Perform deep technical failure analysis based on the physics of failure.
• Initiate, investigate, or coordinate CAPAs involving the products and internal or external processes where noncompliance with procedures, regulatory requirements, and industry standards is found.
• Provide support for the internal and external audits as a member of the QA audit team.
• Advocate for exceptional customer experience through product quality, safety, design, reliability, and usability. 
• Implement a supplier quality program defining approved vendors, conducting supplier audits, and providing feedback on potential partners.
• Implement and scale manufacturing operations quality processes from early builds through pilot and production (incoming, in-process, final inspection, DHR/traceability, and release criteria).
• Partner with Operations/Manufacturing to stand up production workflows, work instructions, routings, training, and shop-floor controls to ensure consistent, repeatable output.
• Define, track, and report quality/manufacturing KPIs (e.g., yield, scrap, rework, defect rates, FPY, incoming acceptance rates, CAPA cycle time, supplier PPM) and drive corrective actions based on trends.
• Establish a quality cadence for operations (MRB rhythm, daily/weekly quality reviews, escalation paths, and continuous improvement actions) and ensure timely closure of issues.
• Drive supplier and incoming quality execution by implementing IQC plans, supplier scorecards, and clear acceptance criteria aligned to risk and reliability targets.
• Build and scale operational quality systems (IQC/in-process/final controls, NCR/MRB workflows, traceability expectations, and production readiness).

Minimum Requirements:

• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or equivalent.
• 5+ years of hands-on experience in the medical device industry.
• Must be obsessed with quality, detail-oriented, well-organized, and have excellent written and oral communication skills. 
• Must have experience implementing manufacturing/operations quality processes and driving KPI-based continuous improvement in a regulated medical device environment.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
• Ability to conduct product investigations, write reports and procedure manuals
• Prior experience with audits, NCRs, complaints, pFMEA, and IQC.
• Experience with medical device HW/FW/SW testing (e.g., IEC 60601, IEC 62304).
• Detail-oriented with strong written and verbal communication skills; able to write reports and procedure manuals.
• Must be able to work well with interdisciplinary teams and to project manage cross-functionally
• Ability to conduct product investigations, write reports and procedure manuals
• Able to work effectively with interdisciplinary teams and project manage cross-functionally.
• Strong analytical skills with a track record of diagnosing and fixing complex problems.

Preferred Requirement:

• Deep technical background in electromechanical devices and robotics.
• Experience in design for reliability, manufacturability, and serviceability.
• ASQ CQE, CRE, CSQE, or CQA certification.
• Understanding of software development lifecycle, architecture, and configuration management.
• Proficient with tools such as Jira, GitHub, GrabCAD, and Arena.
• Strong understanding of statistical methods and process techniques.
• Experience creating FMEAs.
• Experience with database quality and security standards.
• Experience setting up Quality Management Systems and adhering to quality standards.

Why Join Us?

• Be the a quality leader in a mission-driven startup transforming women’s health.
• Own the function end-to-end, from strategy to execution, across all areas.
• Significant exposure to the board and management team as well as the industry leading investors and thought leaders.
• Work with cutting-edge AI-powered imaging technology that is revolutionizing breast cancer detection.
• Drive investor and market engagement at a crucial stage of company growth.
• Make a meaningful impact in a company dedicated to saving lives through better breast imaging.
• Equity & Compensation –ownership in the company’s success, with an equity package aligned with company growth.