79 applicants

Company

Original Job Post

Enovis · 1 week ago

Software Engineer

Dallas, TX

Full-time

Onsite

Mid, Senior Level

5+ years exp

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Health CareManufacturing

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Responsibilities

Improve and maintain existing embedded software for electro-therapy products and related documentation (DHF)

Investigate software-related issues, perform and document root-cause analysis

Coordinate software change activities in collaboration with Project Management, QA, RA, Clinical dept., and product management representatives

Setup or extend test infrastructure and software tools

Implementation of software change, release, and documentation

Organize, document, and participate in software design and code reviews and provides support to manufacturing, servicing and product management department

Contribute to new product development project success in a multidisciplinary, international team

Qualification

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Software DevelopmentEmbedded SoftwareMedical Device IndustryC ProgrammingC#C++PythonBashMCU ProgrammingSTM32ADCDACUARTSPII2CDMAUSBTimersElectronicsSchematic ReadingDebuggersJTAGOscilloscopesLogic AnalyzersSimulatorsLow-level software developmentMedical devicesIEC 62304 2015Risk managementISO 14971

Required

Bachelor's degree in computer science, computer/electrical engineering, information technology or a similar field

5 years experience in software/embedded software development in the Medical Device Industry or other highly regulated environment

Proficient in C, good knowledge of other programming languages including C#, C++, Python, Bash

Strong experience in low-level MCU programming like STM32, involving peripherals such as ADC, DAC, UART, SPI, I2C, DMA, USB, Timers

Fundamental understanding of electronics, capable of reading and understanding schematic around the MCU

Experience with development tools such as debuggers (JTAG), oscilloscopes, logic analyzers, simulators

Preferred

Proven track record with low-level software in a MS Windows based environment development

Motivation and interest to work in the highly regulated medical devices world

Experience with IEC 62304:2015 – Medical device software including architecture/documentation/testing of moderate and high level of concern classified products

Experience working on Class II Medical Devices and appropriate use of Risk Management standard ISO 14971

Experience with FDA guidance documents related to medical device software. Demonstrate an understanding of design control requirements for medical devices and successfully navigate the product development process to release successful products to the market

Solid understanding and appreciation of SDLC process and tools (GIT, JIRA, ALM, etc…)

Ability to work independently with minimal oversight

Ability to work under strong timing and performance pressure

Ability to explain complex technical issues and justify solutions with data

Capable of transforming business requirements into technical design

Strong team spirit and ability to evolve in an international and multi-cultural environment

Experience/knowledge of cybersecurity standards applicable to medical device products

Demonstrated understanding of user experience, user-centered design and responsive web design

Design Controls and/or Quality Management Systems training

Experience in battery-powered designs with limited resources (battery, processor power, space, and costs)

Programming experience on mobile platforms (Android and/or iOS) or web frontend and backend