iSono Health · 7 hours ago
Quality Engineer
Sunnyvale, CA
Full-time
Onsite
Senior Level
5+ years expiSono Health is seeking a Quality Engineer to enhance their quality mission through hands-on experience in engineering problem-solving and a passion for best practices in product and process design. The role involves supporting product development activities, ensuring compliance with quality systems, and advocating for exceptional customer experience through product quality and reliability.
Artificial Intelligence (AI)Health CareMedical Device
Hiring Manager
Neda Razavi, MBA
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)
Qualification
Required
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
Strong analytical skills with a track record of diagnosing and fixing complex problems
Preferred
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
Company
iSono Health
iSono Health develops an AI platform for accessible and personalized breast health monitoring
11-50 employees
H1B Sponsorship
iSono Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Early StageTotal Funding
$6.45MKey Investors
JSK InvestmentsNational Science FoundationFoothill Ventures
2025-10-13Series Unknown
2025-03-26Seed· $1.84M
2019-09-18Grant· $0.77M
Leadership Team
Maryam Ziaei
Co-Founder
Shadi Saberi
CTO, Co-Founder
Recent News
2026-01-16
Company data provided by crunchbase