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Director of Software Development - Medical Device (Buffalo)

Director of Software Development - Medical Device (Buffalo)

DeBellis Catherine & Morreale - Corporate StaffingBuffalo, NY, US
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I am a recruiter with a medical device designer / developer and manufacturer of a cutting edge intelligent infusion device that is Bluetooth enabled. We seek a top-flight Director of Software Development from a medical device company to join our team.

Position Summary

We are seeking a Senior Software Manager / Director with deep experience in embedded systems and connected device ecosystems. This role will 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 strong 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

  • Bachelors or Masters 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 your experience. Ideally, someone from an infusion device company.

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    Director Of Development • Buffalo, NY, US