On-Site Medical Device Software Engineering Lead

DEKA Research and Development

Manchester (NH)

On-site

USD 150,000 - 230,000

Full time

4 days ago

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Job summary

DEKA Research & Development is seeking a Medical Device Software Engineering Lead to guide architecture and delivery for a complex FDA-regulated device. This hands-on leadership role spans embedded drivers, Android UI, and cloud data exchange.

On-site role with no remote or hybrid options. You will lead engineers, plan releases, and ensure compliance with FDA design controls and IEC 62304/ISO 14971 while mentoring peers and driving robust software practices.

Qualifications

Bachelor's degree in Computer Science or equivalent.
5+ years of relevant experience in medical devices or safety-critical, regulated products.
Experience as a technical lead or mentor to other engineers.
RTOS/embedded systems development experience (FreeRTOS or embedded Linux).
Experience with Android application development and system-level architecture.
Familiarity with FDA design controls and IEC 62304 / ISO 14971.

Responsibilities

Own and drive software architecture across embedded, Android, and cloud layers.
Design, implement, and verify medical device software with focus on reliability and maintainability.
Lead a team of engineers: cadence, planning, standups, reviews, and progress tracking.
Plan releases and ensure features and bug fixes are defined and tested before release.
Lead design, architecture, and code reviews and mentor junior engineers.
Solve complex system-level problems across hardware and software boundaries with cross-discipline partners.
Define, analyze, and maintain software requirements and interfaces within FDA design-controls.
Perform software risk and failure mode analysis per IEC 62304 and ISO 14971.
Develop and verify software test procedures to ensure requirements are met.