Location: must be onsite McHenry, IL 2-3 times per week
Salary: $95k - $110k
Type: direct hire
ESSENTIAL FUNCTIONS
Design and implement safety-critical software features for enteral feed pump systems, including precise flow rate control, occlusion detection, and alarm management
Develop and maintain IEC 62304 compliant software documentation, including software requirements specifications, architecture documents, and risk analysis
Participate in FMEA -Failure Mode and Effects Analysis (FMEA) is a process for identifying potential failures in a system and their consequences. sessions and implement appropriate software mitigations for identified risks
Experience in resolving complex technical problems using strong analytical skills
Experience with FDA regulated medical device software development lifecycle and design controls (21 CFR 820.30)
Contributes to design verification & validation as part of a team
Establish software requirements from broad and generic product requirements
Demonstrated proficiency with Git open-source version control system that helps software development teams manage source code version control, including experience with branching strategies, code review processes, and managing multiple development streams in a regulated environment
Strong familiarity with common embedded serial protocols (SPI, I2C, UART) and USB device implementation. Familiarity with debugging protocols (JTAG/SWD).
Experience with network protocols (TCP/IP, WiFi, or Ethernet) and wireless communications (Bluetooth/BLE) and knowledge of secure communication principles is a plus.
Experience with motor control algorithms and sensor integration for medical systems
Familiarity with hardware development, debugging tools, reading schematics
Experience working in Agile development teams, including sprint planning, daily standups, retrospectives, and adapting Agile practices to meet regulatory requirements
Ability to bridge cross-functional project needs through extensive system integration experience with microprocessor based hardware and software
Manage time and objective priorities among multiple competing tasks, providing updated timelines as priorities are assessed
Strong command of multiple IDEs with ability to set up and maintain development environments compliant with IEC 62304 requirements
EDUCATION and CRITICAL SKILLS/EXPERIENCE
Bachelor's degree in Software, Computer, or Electrical Engineering or related field required along with solid experience in an embedded programming environment.
Minimum three years' experience in design and implementation of complex embedded software electromechanical systems (experience in medical devices preferred).
Proficiency in computer languages including C, C++, and Python coupled with knowledge of computer principles, communications, networking and operating systems.
Ability to bridge cross-functional project needs through extensive system integration experience with microcontroller based hardware and software.
Applied knowledge of regulatory guidance on design controls and software validation.
Demonstrable experience bringing at least one regulated software product through a regulatory clearance process
Preferred understanding and hands-on implementation experience with ISO 13485 quality management systems a specific quality management system (QMS) standard designed exclusively for the medical device industry, ensuring consistent quality and patient safety throughout the entire lifecycle of a medical device, from design and production to disposal and IEC 62304 software development processes, including:
Software maintenance planning
Problem resolution tracking
Change management processes
Configuration management
Software architecture documentation
Risk management documentation
PHYSICAL DEMANDS Travel up to 10% of the time, including occasional international travel