Research and Development Engineer II

About CloudCath

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 Opportunity:

CloudCath 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 Arrangement

• Hybrid role based in San Francisco headquarters; minimum 3 days/week on-site.
• Periodic travel (~10%) to vendors and manufacturing partners is required.

Responsibilities:

Design & Engineering

• Lead 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 Support

• Conduct 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 Support

• Respond 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 & Regulatory

• Perform complaint investigations, root cause analyses, and risk assessments in compliance with FDA 21 CFR Part 820 and ISO 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 per ISO 14971.

Analytics & Device Performance

• Monitor 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 Qualifications

• Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering (or related discipline).
• 3 years of R&D or sustaining engineering experience in a medical device environment.
• Strong understanding of FDA Class II device regulations, including 21 CFR Part 820.
• Familiarity with ISO 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 Qualifications

• Experience in early-stage or commercialized medtech companies.
• Exposure to connected health or remote monitoring devices.
• Working knowledge of embedded systems, sensors, or data analytics.
• Hands-on experience with root cause analysis and statistical tools (e.g., JMP, Minitab, Excel).

What We Offer

• Mission-driven work that directly improves patient outcomes.
• Exposure to the full product lifecycle, from concept to commercialization.
• Collaborative startup culture with high learning velocity.
• Competitive compensation and benefits package.