Software Engineer VI

Indianapolis, IN/Charlotte, NC

About SonaCare Medical:

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

Duties and Responsibilities

Manage software engineers and software development projects to implement effective and high-quality software solutions;

Collect, analyze, and document user requirements;

Perform project management, ensure system quality and oversee content management;

Coordinate with CTO and company-wide leadership regarding software development projects;

Design, modify, develop, support, install, and document HIPAA compliance software applications, including HIFU Treatment software, graphical user interface software, and probe motion control software;

Participate in software quality control and validation processes through development, code review, and/or execution of test plan/cases/scripts;

Train software engineers and applicable employees throughout company; Identify process deficiencies and propose improvements;

Assist Hardware Development teams with design and testing of custom electronics, to the extent they require software;

All other duties as assigned

Qualifications/Specifications

Six years of software development experience, required;

Three years of project lead experience, preferred;

Development Experience with Java, JNI, C++, and Windows Environments, required;

Experience with international standards for quality systems, required;

Knowledge of SharePoint technologies preferred;

Understanding of software development processes within a medical device manufacturing environment, including general knowledge of Good Manufacturing Practices, Good Engineering Practices, FDA Quality System Regulation, ISO 13485, Healthcare compliance,HR-261 Software Engineer VIHR-261 Revision 2.0 Page 2 of 2 Draft/Reviewand applicable regulations and industry standards regarding clinical research and regulationof medical devices;

General knowledge of IEC 62304 Medical Device Software – Software Life Cycle Processes,FDA General Principles of Software Validation Final Guidance for Industry and Staff, FDAGuidance for the Content of Premarket submissions for Software Contained in MedicalDevices;

Experience in clinical environments a plus!

 

Apply For This Position

Latest News

07 November 2019

Charlotte, NC Nov 07, 2019 – SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to report the publication of multiple articles highlighting...

07 November 2019

Charlotte, NC Nov 07, 2019 – SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to report on the successful conclusion of its...

Connect With Us

Copyright © 2020 Sonacare Medical

Design & Development By Medtech Momentum

Search

(888) 874-438410130 Perimeter Pkwy, Suite 250 Charlotte, NC 28216