Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.

At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

Company Overview

Outset Medical is a commercial-stage company delivering first-of-its-kind technology into the growing dialysis market.Our mission is to dramatically improve not only the care experience for patients, families, providers and physicians alike but to also free providers from having to rely on expensive clinic infrastructure.Outset’s Tablo® Hemodialysis System, with real-time water purification and dialysis fluid production integrated in a single, compact system, functions like a dialysis clinic on wheels. Wireless data, sensor-based automation, and an animated touchscreen aim to make Tablo easy to learn and easy to use for healthcare professionals and patients alike. Tablo is FDA cleared for use in the clinic, home,



and hospital setting.

Position Overview

The Senior Consumables Engineer supports the design, development, characterization, verification and validation, and continuous improvement of product designs and associated manufacturing processes for disposable medical devices and consumables. Working closely with Development QA, Supplier QA, Regulatory, Manufacturing Engineering, and suppliers, this role applies engineering principles, statistical methods, and risk-based approaches to develop robust designs and repeatable manufacturing processes. The position is responsible for design, prototyping, feasibility and characterization testing, design verification, supplier process validation, and troubleshooting and improvement of parts and assemblies utilizing technologies such as injection molding, extrusion, ultrasonic welding, solvent and adhesive bonding, manual assembly, and sterilization. Projects will focus primarily on high-volume disposables and consumables but may also include support of associated durable products and accessories. The position is onsite at the Outset Medical factory facility in Tijuana, Mexico as part of the R&D; team based in San Jose, California.

Essential Job Functions

- Uses experience and knowledge of plastic disposables design, mechanical engineering, assembly techniques and sterilization in the design, development,



and continuous improvement of disposable products.
- Creates and translates design concepts into 3D CAD and detailed 2D drawings, with emphasis placed on design for low-cost, high-volume manufacturing.
- Owns design development activities from design synthesis through production phase, including detailed analysis, debug and resolution.
- Collaborates with suppliers and Outset Quality Engineering to evaluate manufacturability and inspection of component designs.
- Selects and specifies materials, off-the-shelf components, and packaging for sterile disposable products.
- Collaborates with manufacturing engineers to develop tube bonding, ultrasonic welding, manual assembly processes, and product acceptance testing including tensile, leak and flow, and functional tests.
- Supports equipment qualification, fixture development, inspection methods, and process automation initiatives.
- Contribute significantly to verification testing and validation testing of components and assembled products, including generating test plans, protocols and reports, and overseeing test execution.
- Applies statistical methods to analyze data, evaluate process capability, and makes data-driven recommendations and decisions.
- Works with Outset Supplier Quality Engineers to validate supplier molding, extrusion, sterilization, and other special processes. Reviews supplier validation results for conformance with part specifications and demonstration of process capability.
- Drives process and product improvement activities to promote product quality, overall manufacturing cost, efficiency and manufacturability.
- Performs troubleshooting of component and system level issues identified in manufacturing, reliability

📌 Senior Consumables Engineer (Tijuana)
🏢 Outset Medical
📍 Tijuana