The Company The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics, a bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner than existing methods, saving patients suffering from drug-resistant infection.

The Job The person for this job will be a key member of our company, contributing to development of firmware for Specific’s medical diagnostic instruments. You will be a lead developer on a commercial medical device platform. You will define, grow, and implement the core control functionality of the instrument. You will have the opportunity to work on the hardware layer that interacts with various devices developing instrument control firmware.

The job responsibilities include deploying, operating, and maintaining application instances and development of automation wrappers for off the shelf test equipment.

You will be a key contributor in a fast-track development program for a medical diagnostic system, and leadership experience in software development and test of FDA-regulated medical devices in an ISO 13485 quality environment is critical. The job includes reviewing and documenting software in compliance with medical device software standards including IEC 60601, 61010, and 62304. Developing against requirements includes evaluating software usability and error handling procedures.

You You will be a key member of our development staff. You should have direct experience in the engineering development, verification, and validation of regulated medical device firmware. You will be part of a multi-disciplinary technical team. Demonstrated interpersonal skills and the ability to lead technical teams will be essential. Our development is very diverse, and you will have the opportunity to work on various technologies and develop various aspects to our solution. You should be excited by the prospect of working in a dynamic, entrepreneurial environment and the following qualifications:

• 5 or more years of experience in hands-on development and troubleshooting of embedded targets, preferably medical instruments.
• Experience working with microcontrollers in an embedded system environment with various sensors, electro-mechanical and electro-optical systems.

• Demonstrated firmware development, validation, and deployment of embedded C for critical real-time data acquisition, analog and digital I/O sensors, algorithms, error-handling and communication interfaces (UART, I2C, SPI)

• Proficiency with Python
• Development of medical devices in a regulated industry.
• Experience with IEC 62304 medical device development, test, and documentation
• Experience with source control and defect tracking systems (Github, Jira, etc.)
• Experience with electronics and related test equipment (e.g. Oscilloscope)
• Bachelor’s Degree in Computer Science, Electrical Engineering, or other related field preferred.
• Authorized to work in the US and full fluency of the English language is a must.