Senior Consumables Engineer

Company Overview 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 testing and field, including root cause analysis, corrective actions, and preventative actions. - Generates and maintain relevant design documentation, including risk analyses, FMEAs, engineering drawings, theory of operations and system architecture documents - Interfaces with vendors and/or direct or coordinates prototype fabrication and assembly activities to ensure products and systems conform to engineering specifications; documents designs and manufacturing recommendations. - Provides mechanical engineering expertise for the continuous improvement of product and process. - Accurately and thoroughly document work in support of ISO13485, FDA GMP and the requirements of all other relevant standards and all necessary documentation for planned FDA filings. - Partners and communicates effectively across the organization and with key Outset partners to support rapid system development. - Approximately 10% travel required, including international Requirements/Qualifications - S. in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related technical discipline. - 5-7 years of design and development engineering experience in the medical device industry. - Experience supporting development of disposable medical products. - Knowledge of process validation methodologies (PPAP, IQ, OQ, PQ) and medical device quality system requirements (FDA Quality System Regulations, GMPs, and ISO 13485). - Experience with statistical methods and analysis tools such as Minitab. - Working knowledge of Design of Experiments (DOE), process capability analysis, and statistical sampling methods. - Experience with product and process development for assembly in a cleanroom environment. - Experience supporting manufacturing technologies such as injection molding, ultrasonic welding, assembly processes, leak testing, sterilization, and other related disposable-device manufacturing processes. - Strong analytical, technical, and problem-solving skills for detailed component issues and/or system level interactions. - Experience leading and managing engineering projects. - High level of proficiency on 3D CAD design package, preferably Solidworks, including drafting standards and GD&T Other Skills/Abilities - Experience in high volume consumables. Preference given to experience in high volume consumables which physically interface with capital equipment. - Experience working with external manufacturing and molding partners, particularly involving them early in the design process to optimize for cost and manufacturing method selection. - Understanding and experience with blood contacting products, including hemodynamics, flow characteristics and material/geometry biocompatibility. - Understanding of elementary chemistry and biochemistry. - Six-Sigma Green or Black Belt certified. Company Culture At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career. An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams. Privacy is important to us. Please review our Applicant Privacy Notice. Important Notice We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at [email protected]. EQUAL EMPLOYMENT OPPORTUNITY STATEMENT Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.