Director of Software Development - Medical Device

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

Preferred Qualifications

What We Offer

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.