Director of Software Development - Medical Device

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.

• 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.

• 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, STM
  32, 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.

• 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.

• 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.