What are the responsibilities and job description for the Director of Software Development & Engineering - Medical Device position at DeBellis Catherine & Morreale - Corporate Staffing?
My client is a medical device start-up company with over five years of development invested in cutting-edge infusion technology. The company is located in the Buffalo/Rochester, NY area
The device is a touch-screen-driven system that connects to hospital networks via Wi-Fi and incorporates advanced cybersecurity features. It supports Bluetooth and NFC connectivity. It uses proprietary vision-based technology to directly measure flow rate.
The initial product launch is focused on medication delivery from IV bags, with subsequent product releases planned to support syringe-based delivery. The 510(k) submission planned for June 2026
We need someone with experience in embedded systems & connected device ecosystems. Will lead a team developing regulated embedded medical devices that interface with cloud infrastructure and/or mobile applications. Hands-on embedded expertise, strong systems engineering mindset, managing full software lifecycle development in compliance with IEC 62304 & FDA regs
Partial Required Qualifications
- Bachelor’s in Computer Engineering, Software Engineering, Electrical Engineering
- 10 years of experience in embedded software development.
- 5 years of S/W management experience.
- Proven experience with embedded Linux, RTOS, microcontroller platforms (ARM, STM32, etc.)
- Experience leading development for Class II or Class III medical devices
- Experience with medical device development under IEC 62304 & FDA design control processes.
- Experience managing products involving IoT/cloud connectivity or mobile application interfaces.
- Strong grasp of system-level design and integration.
- Working knowledge of cybersecurity risk assessment
- Hands-on experience with integration testing frameworks, version control (e.g., Git), and CI/CD/CT pipelines.
Up to $225,00 base salary, based on experience Annual Bonus
You must be able to relocate to the Buffalo/Rochester, NY area. This role requires 100% on-site
Salary : $22,500