Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.
The Staff R&D Engineer will play a key role in enhancing the current and design/develop the new generation(s) of the Tablo Hemodialysis System while also supporting the existing platform. This individual will work closely with cross functional team members to take ideas from concept to implementation. The individual is also be expected to support prototyping, testing, troubleshooting, risk management and documentation activities. This position requires a systems approach to problem solving and the ability to understand electromechanical systems and physical processes associated with fluid flow control.
Essential Job Functions
- Research, design and development of new electro-mechanical technologies/solutions.
- Leverages experience and knowledge of mechanical engineering (fluidics/thermal), and medical devices to participate in the design and development of Outset’s products and intellectual property.
- Defines the Component and System Requirements.
- Experience with designing hardware products in an FDA or other regulated industry; comfortable with concepts of design input, design output, traceability, and risk analysis.
- Strong understanding of component selection criteria, and design for reliability and manufacturability.
- Works closely with other engineering groups and be able to make designs with a “systems” perspective.
- Design and create electromechanical prototypes using in-house rapid prototyping capabilities.
- Perform component, module and system level testing on test fixtures, functional test beds (FTBs), prototype machines & Tablo systems and generate data. Analyze data and present/report findings to the engineering organization.
- Contribute significantly to verification and validation testing, including generating test plans, protocols and reports, and overseeing test execution.
- Performs failure and root cause investigations of component and system level issues identified in R&D, manufacturing, reliability testing, field and provide solutions.
- Ability in designing and implementing hardware solutions in a fast pace environment.
- Proven experience and proficiency using CAD to design and document both large and small parts and assemblies.
- Generate and maintain relevant design documentation, including risk analyses, FMEAs, engineering drawings and system architecture documents.
- Interfaces with vendors and/or directs 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.
- Maintains awareness of the Dialysis IP landscape and actively seeks opportunities to enlarge Outset’s patent portfolio.
- B.S. in Mechanical Engineering or equivalent.
- Minimum of 8 years of relevant experience doing electro-mechanical product design and development in the medical device industry.
- High level of proficiency fluidics, thermal and 3D CAD design package, preferably Solidworks.
- Defining Design of Experiments, understanding of data analysis and statistical methods.
- Demonstrated knowledge of sound design principles and practices.
- Demonstrated knowledge of Risk Management techniques and CAPA process.
- Experience with capital equipment is highly desirable.
- Excellent verbal and written communication with all levels of technical and operating management.
- Highly motivated, able to take calculated and bold initiatives to meet expectations while maintaining the ability to handle multiple projects and meet deadlines in a timely manner.
- Experience with pumps, valves, sensors and other fluid control system components desired.
- Possesses excellent interpersonal skills and can work effectively with a diversity of personalities.
- Must be approachable, show respect for others, and be able to present data effectively to different audiences.
- Maintain state-of-the-art knowledge of the systems design of competing products.
- Results oriented with the ability to balance other business considerations.