Research and Development Engineer II

CloudCath is a medical technology company transforming peritoneal dialysis (PD) care through advanced remote monitoring. Our FDA‑cleared platform enables early detection of complications, enhances care team responsiveness, and supports patient safety. We are a mission‑driven team passionate about improving outcomes and quality of life for patients with kidney disease.Learn More About CloudCath:To learn more about our technology, mission, and how we’re transforming peritoneal dialysis monitoring, visit www.cloudcath.com.CloudCath is committed to advancing remote infection detection with cutting‑edge technology that empowers patients and healthcare providers to improve outcomes, safety, and quality of life for individuals managing at‑home peritoneal dialysis.Join us in transforming the lives of peritoneal dialysis patients and shaping the future of remote infection monitoring.The OpportunityCloudCath is seeking a highly motivated Research and Development Engineer II to drive innovation and operational excellence across our medical device platform. This individual will support product design, manufacturing, post‑market surveillance, and continuous improvement activities for our Class II medical device system.The ideal candidate is a hands‑on engineer who thrives in a fast‑paced, interdisciplinary environment—comfortable working across hardware, firmware, software, and quality systems. This position requires strong ownership, technical curiosity, and the ability to move seamlessly between design, operations, and field support functions.Work ArrangementHybrid role based in San Francisco headquarters; minimum 3 days/week on‑site.Periodic travel (~10%) to vendors and manufacturing partners is required.ResponsibilitiesLead and support technical design change activities across electromechanical, software, and firmware components.Execute verification and validation testing, risk management updates, and documentation under design control.Maintain design traceability, update requirements, and contribute to design reviews and technical reports.Support change control processes in the Quality Management System (QMS).Manufacturing SupportConduct device servicing, rework, and failure investigations.Collaborate with contract manufacturing partners to troubleshoot production issues.Coordinate supplier communications and track follow‑up actions.Review and approve Device History Records (DHRs) and Manufacturing History Records (MHRs).Customer & Field SupportRespond to inbound product inquiries from healthcare providers and patients.Assist with patient onboarding, training coordination, and troubleshooting.Collaborate with engineering and clinical teams to resolve field issues efficiently.Quality & RegulatoryPerform complaint investigations, root cause analyses, and risk assessments in compliance withFDA 21 CFR Part 820andISO 13485.Maintain and document complaints, nonconformances, and CAPAs.Support internal audits as a SME, regulatory inspections, and continuous improvement of the QMS.Contribute to Design History File (DHF) and risk management documentation perISO 14971.Analytics & Device PerformanceMonitor device field performance using internal analytics tools.Track key performance and quality metrics to identify emerging trends.Support data‑driven improvement initiatives and reporting to cross‑functional teams.Required QualificationsBachelor’s degree inBiomedical, Mechanical, or Electrical Engineering(or related discipline).3+ yearsof R&D or sustaining engineering experience in amedical device environment.Strong understanding ofFDA Class II device regulations, including21 CFR Part 820.Familiarity withISO 13485,ISO 14971, and design control methodologies.Experience with complaint handling, CAPA, and device master record documentation.Excellent technical writing, communication, and documentation skills.Detail‑oriented, self‑motivated, and capable of managing multiple priorities.Preferred QualificationsExperience inearly‑stage or commercialized medtechcompanies.Working knowledge of embedded systems, sensors, or data analytics.Hands‑on experience withroot cause analysisandstatistical tools(e.g., JMP, Minitab, Excel).What We OfferMission‑driven work that directly improves patient outcomes.Exposure to thefull product lifecycle, from concept to commercialization.Collaborative startup culture with high learning velocity.Competitive compensation and benefits package.Seniority levelMid‑Senior levelEmployment typeFull‑timeJob functionEngineering and Information TechnologyIndustriesMedical Equipment ManufacturingLocation: San Francisco, CA #J-18808-Ljbffr