Description - Senior Software Test Validation Engineer
The Senior Software Test Validation Engineer is responsible for supporting development of medical devices by participating in all aspects of software test activities including requirement reviews, test methodology design, integration testing and software verification and validation activities.
The Senior Software Test Engineer will be responsible for supporting the goals and objectives of product development by developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical devices. This individual will execute test cases per protocol and document the results. This individual will participate in the development and review of software requirements and will contribute to the design and implementation of Software Testing processes on projects. They will work closely with Software Engineering team to ensure implementation and application of Software Validation principles throughout the development process. They will provide technical direction and hands-on assistance for testing projects. The candidate will also review existing processes and make recommendations & implement software V&V process improvements going forward (including Agile testing and automated testing).
You will have an enormous opportunity to make a large impact on the design, architecture, and implementation of cutting edge products used every day, by people you know. We are looking for talented and passionate Sr. Software Test Engineer to be part of an exciting team
Duties and Responsibilities
Process improvements: Using the leading-edge software test processes and methodologies, capable of reviewing existing processes, making recommendations and implementing improvements within the software organization
Requirement reviews: Capable of reviewing, understanding and determining the scope of testing required
Test method and prototype design: Capable of developing test methodologies for addressing SW requirements and system testing
Test Protocol design & creation: Capable of writing clear, concise, detailed and readable test procedure documentation following guidelines and templates
Integration testing: Preliminary verification of test methodologies proposed, test protocols written and performance of SW against requirements
Software Validation: Formal test execution of SW validation protocols (per user needs)
Software test initiatives such as automated testing, improved test documentation, etc…
Successfully collaborate with both software and hardware product teams
Basic Qualifications
Bachelors of Science in Computer Science, Electrical Engineering, Bioengineering, System Engineering, or Quality Engineering
5+ years verification and validation experience in a software quality assurance environment
Experience in software testing, verification, and validation, including an understanding of “white box” and “black box” testing, test design, test tools and methods, test documentation, test management, test traceability, defect management and tracking is required.
Experience in defining test strategy, designing and developing test cases from software requirements, architecture designs, and code of complex embedded real-time systems
Fundamental C programming skills
Knowledge of embedded software design, development and debugging
Ability and desire to work in a fast paced team environment where you will interface regularly with electrical, back-end software, mechanical and system test engineers on system level design and test development.
Have experience in writing system specifications (SPEC), product requirements documents (PRD) and prototype test plans (TP)
The ability to work with cross-functional teams to create a fully functional system and maintain aggressive development schedules.
Preferred Qualifications
An advanced Degree in Computer Science, Electrical Engineering, Bioengineering, System Engineering, or Quality Engineering
Familiarity with scripting languages like Shell, Perl and Python is an advantage
Familiarity with testing mobile apps (iOS or Android)
Prior experience in software algorithm testing a big plus
Software engineering experience in a regulated industry (e.g. FDA 21 CFR 820, the Quality System Regulation, ISO 13485, and IEC 62304)
About Scanadu: http://www.scanadu.com
Scanadu is a Silicon Valley medtech company developing a portfolio of medical devices for consumers. The company is seeking FDA clearance for all its products before bringing them to market to ensure clinical-grade accuracy. The first device is the Scanadu Scout™- a compact, portable electronic device designed to measure different physiological parameters, including temperature, heart rate, clipless blood and cuffless oxygenation and diastolic/systolic blood pressure. The second is a urine test kit designed to empower people to give and monitor early information about gestational diabetes, liver, kidneys, urinary tract infection, or metabolism.