Company Overview

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.  

Position Overview 

We are seeking a Staff Software Engineer that can directly impact the experience of patients and clinicians as well as Outset business operations with their breadth of skills and can-do attitude. Daily activities will include requirements definition, design, implementation, and testing of embedded software as part of a cross functional team with a key focus on intelligent medical systems and components. The candidate should bring a systems approach to problem solving and the ability to understand complex electromechanical systems. The candidate should be fluent in Object-oriented design, and C/C++ and have experience with both real-time operating systems and Linux. UML and Java and/or Python programming experience are highly desirable.

Essential Job Functions 

  • Leverages experience and knowledge of systems design, software engineering, and medical devices to lead in the design and development of the software for Outset products and intellectual property.
  • Participates in risk assessment, requirements definition, software architecture and detailed design, implementation, and software verification and validation.
  • Defines tasks associated with all phases of software development and provides accurate estimates of required effort and project completion dates.
  • Provides software engineering expertise for the continuous improvement of product and process.
  • Accurately and thoroughly documents work in support of ANSI/AAMI/IEC 62304:2006, ISO13485, FDA GMP and the requirements of all other relevant standards and all necessary documentation for planned FDA filings.
  • Leverage experience and knowledge of systems design, software testing, and medical devices to develop software verification protocols for Outset products.
  • Apply Object-Oriented Analysis/Design and UML to software architecture and design.

Requirements/Qualifications 

  • PhD or Masters in Biomedical/Computer/Electrical Engineering or equivalent.
  • Proven exceptional analytical and problem-solving skills applied to complex electromechanical systems.
  • Ability to read digital board schematics and datasheets; familiar with microprocessor architectures, especially ARM.
  • Experience with pumps, pressure and flow sensors, valves and fluid control system components desired.
  • Minimum of 2-5 years’ experience in C/C++, embedded firmware/software design, development, debug and test.
  • Minimum of 2-5 years’ experience in medical device or instrumentation software desired.
  • Demonstrated proficiency with source code control, issue tracking, and requirements management systems.
  • Java and/or Python programming desired.

 Other Skills/Abilities 

  • 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.
  • High level of initiative with ability to self-manage, 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.
  • Flexible in daily schedule, tasks required and problem solving, while maintaining compliance with company policies and procedures.

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