Job Description

Basic Purpose of Position: Design, develop and test software contained within complex medical devices including communication software to support interoperability. Work with other engineering disciplines (e.g., mechanical, electrical, system) to create new medical devices that meet product requirements. Execute tasks along the complete software development lifecycle including creating documents to support regulatory compliance. Communicate with customer and other team members to produce desired results.

 

 

Primary Responsibilities

• Support the customer in developing realistic and testable requirements for the product and its software.

• Develop sufficient working medical knowledge for the product under development.

• Design solutions for customers utilizing knowledge of development platforms, operating systems, networks, peripherals of general and specific nature, software tools and applications. Mold initial concepts into a fully developed cohesive software architectures.

• Integrate software components into fully functioning system including custom hardware.

• Develop and document unit tests to meet quality assurance requirements.

• Perform software development, document creation and project review tasks as needed.

• Troubleshoot, debug and upgrade existing software releases.

• Communicate concisely and professionally regarding product designs and technical details. Provide regular status reports and updated estimates for completion.

• Use the Quality Management System to complete assignments along with following Sparton policies and procedures. Comply with appropriate regulatory guidelines and industry standards.

• Apply hazard analysis, failure analysis, and risk mitigations as required within the development lifecycle.

• Ability to work in and sometimes lead small teams to document and implement software design and develop and execute software test protocols in compliance with design control processes.

• Travel as appropriate to support interactions with customer.

• Ensure that all assignments are performed in compliance with all applicable Federal, State, Provincial and Company safety and health regulations, and where applicable, proper personal protective equipment is utilized.

 

 

Job Requirements

Minimum Requirements :

 

• Bachelor's degree in a computer software related field of study, Electrical Engineering or similar equivalent. Advanced degree(s) a plus.

• 7+ years of applicable experience developing embedded/application system software.  Medical or other regulated industry experience preferred.

• Solid working knowledge of and experience with C, C++ and C# programming languages required  C#, Java, Python, QML, and other languages a plus.

• Solid experience with object oriented design principles.

• Experience developing on microprocessor, DSP, and/or single board computer platforms.

• Experience implementing communication protocols and interfacing with system hardware and

   external systems.

• Understanding of real time embedded operating systems.

• Experience with iOS/Android mobile app development a plus.

• Knowledge of and experience with the entire Software Development Life Cycle (SDLC) process.    • .

• Experience with IEC 62304 a plus.

• Experience in medical product development environment a plus.

• Experience working under a documented Quality Management System (e.g., ISO 9001, ISO 13485) maintaining quality records throughout project execution.

• Current experience with software development tools (compilers, IDE, debuggers, source code control, static code analyzers, unit testing, defect tracking) a must.

• Experience with bare-metal, RTOS, and Linux embedded development platforms. Qt experience a plus.

• Competent with Microsoft Office (Word, Excel, PowerPoint) and Microsoft Project.

• Experience in generating design documentation, ability to write technical reports, and provide cost and schedule estimates.

• Must show high initiative, motivation, and have the ability to work independently

• Excellent communication skills and ability to work within a team environment to accomplish goals.  

• Candidate will need to be a team player, problem solver, and a results driven individual who is comfortable working a fast-paced environment in order to be successful in this role.