Principal Embedded SW Engineer

San Jose, CA

Posted: 04/01/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008457

Company Overview 

This company is a privately held company backed by a top-tier syndicate of investors, including Fidelity, T. Rowe Price, Perceptive Advisors, The Partner Fund and Warburg Pincus. We are a pioneering medical technology company focused on reducing the cost and complexity of dialysis. The company’s Tablo™ system is the consumer product version of what today is a terribly complex and prohibitively cumbersome machine for patients to use themselves. We combined consumer product simplicity, wireless data transmission and real-time integrated water purification to enable dialysis anytime, in any setting, managed by anyone. 

Tablo is the first new dialysis technology approved by FDA in over 15 years. Designed to dramatically improve the care experience for patients and the cost-efficiency for providers and payers, Tablo is aimed at enabling service model innovation in a space that has not fundamentally changed since the 1980s. The company is in the early stages of full commercial launch in US dialysis clinics and hospitals, with a clinical trial underway to expand FDA clearance to include the use of the device at home. 

Position Overview 

We are seeking a Staff or Principal Software Engineer that can directly impact the experience of patients and clinicians as well as the compnay 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 also have 1) Java programming skills and the ability to develop GUI software within an existing framework and/or 2) Python programming skills and the ability to develop scripts for data analysis, tool support, or automated testing. 

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 company 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 provide 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 company products. 

* Support manufacturing by designing/verifying test fixture software or other software used during production. 

Requirements/Qualifications 

* M.S. in Electrical/Computer Engineering or equivalent 

* Proven exceptional analytical and problem-solving skills applied to complex electromechanical systems. 

* Minimum of 7 years’ experience in C/C++, embedded firmware/software design, development, debug and test. 

* Minimum of 2 years’ experience in medical device software. 

* Professional experience in Java and/or Python programming. 

* Ability to read digital board schematics, datasheets; familiar with microprocessor architectures, especially ARM. 

* Experience with pumps, pressure and flow sensors, valves and fluid control system components desired. 

* Demonstrated proficiency with source code control, issue tracking, and requirements management systems. 

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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