Job Description
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.
- Demonstrated experience utilizing embedded real-time 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
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