DeBellis Catherine & Morreale - Corporate Staffing
Director of Software Development - Medical Device (Buffalo)
DeBellis Catherine & Morreale - Corporate Staffing, Buffalo, New York, United States, 14266
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.
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.