Senior Consumables Engineer

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

• BS. 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.