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Job description
Director of Software Development - Medical Device
We are seeking a Senior Software Manager/Director with deep experience in embedded systems and connected device ecosystems to lead a multidisciplinary team developing regulated embedded medical devices that interface with cloud infrastructure and/or mobile applications. The ideal candidate brings hands-on embedded expertise, a systems engineering mindset, and a track record of managing full software lifecycle development in compliance with IEC 62304 and FDA regulations.
Key Responsibilities
Lead and mentor a team of embedded software engineers, systems engineers, and test engineers.
Drive architecture, design, development, and validation of embedded software in complex medical devices.
Manage the delivery of software components that interact with cloud platforms and/or mobile applications.
Ensure compliance with regulatory standards, particularly IEC 62304, ISO 14971, ISO 27001, and FDA 21 CFR Part 820.
Define and enforce software cybersecurity controls, configuration management, and access protocols.
Own the technical roadmap, design reviews, code reviews, integration strategy, and test coverage across embedded platforms.
Collaborate cross-functionally with Systems, Electrical, Mechanical, Quality, and Regulatory teams to deliver safe, effective, and high-quality software.
Oversee and improve the use of tools and processes for configuration management, integration testing, and automated builds/releases.
Participate in hazard analyses and risk management reviews related to software.
Required Qualifications
Bachelor’s or Master’s degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field.
10+ years of experience in embedded software development.
5+ years of technical leadership or software management experience.
Proven experience with embedded Linux, RTOS, microcontroller platforms (ARM, STM32, etc.).
Prior experience leading development for Class II or Class III medical devices.
Direct experience with medical device development under IEC 62304 and FDA design control processes.
Experience managing products involving IoT/cloud connectivity or mobile application interfaces.
Strong grasp of system-level design and integration, including hardware/software co-development.
Working knowledge of cybersecurity risk assessment, secure boot, encryption, authentication, and network security controls.
Hands-on experience with integration testing frameworks, version control (e.g., Git), and CI/CD/CT pipelines.
Excellent communication, project planning, and cross-functional collaboration skills.
Preferred Qualifications
Experience with over-the-air (OTA) update systems, Bluetooth, Wi-Fi, or cellular-connected devices.
Familiarity with tools like Jira, Jenkins, Docker, Yocto, and static code analysis tools.
Certification or training in cybersecurity standards such as UL 2900, ISO 27001, or NIST 800-53.
What We Offer
Opportunity to shape next-generation medical technology.
Work with a passionate and experienced team across software, systems, and regulatory.
Competitive compensation and benefits.
A fast-paced, collaborative environment focused on innovation and quality.
Prefer someone already living in the Buffalo/Rochester, NY area, but will consider hiring someone from outside the area, based on experience. Ideally, someone from an infusion device company.
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Worksite address
buffalo, NY, 14266, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.