Director, Medical Device Software Engineering

Diality Inc.

Irvine (CA)

On-site

USD 180,000 - 280,000

Full time

14 days+

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Job summary

Diality Inc. in Irvine, CA, seeks a Director of Software Engineering to lead software development and verification activities for medical devices, ensuring design controls, cybersecurity, and regulatory compliance across products.

You will shape strategy, build high‑performing teams, and partner with Systems, Hardware, Product, Quality, Regulatory, and Manufacturing to deliver clinically impactful solutions on aggressive timelines.

Qualifications

Demonstrated leadership of software Eng and V&V in regulated environments.
Deep understanding of embedded software, architecture, and system design.
Hands-on OO design, embedded software, C/C++, Python, Linux-based systems, and debugging.
Experience with Agile, Scrum, or V‑Model, including traceability, risk, verification, and release processes.
Experience building software organizations in regulated product development environments.

Responsibilities

Lead Software Engineering and Software Verification & Validation teams across new product development and sustaining engineering.
Define and execute software strategy, architecture direction, staffing plans, and priorities.
Improve software processes using Hybrid Agile methodologies and V‑Model SDLC; drive execution and metrics.
Oversee software lifecycle activities: requirements, architecture, implementation, integration, verification, validation, release.
Ensure compliance with medical device regulations, design controls, cybersecurity, and quality system requirements.
Partner with Systems, Hardware, Product, Quality, Regulatory, Clinical, Manufacturing, Service, and Operations leadership.