Head of Embedded Software Engineering – Medical Devices

Diality

Irvine (CA)

On-site

USD 223,000 - 260,000

Full time

14 days+

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Job summary

Diality is seeking a Director of Software Engineering to lead the Software Engineering and Software Verification & Validation organizations, partnering with Systems, Hardware, Product, Quality, Regulatory, Clinical, Manufacturing, Service, and Operations to deliver medical device software solutions. The role requires deep expertise in embedded software, regulatory compliance, and V‑Model/Agile practices.

The ideal candidate has extensive leadership experience in regulated environments, with

Qualifications

15+ years of software engineering experience with progressively increasing leadership responsibilities in regulated product development.
7+ years of formal leadership experience managing software engineering teams.
Experience leading software development for complex embedded electromechanical medical devices (Class II/III).
Strong knowledge of IEC 62304, FDA software validation expectations, medical device cybersecurity guidelines, and design controls.

Responsibilities

Lead and develop Software Engineering and Software Verification & Validation organizations supporting new product development, sustaining engineering, and connected medical device software systems.
Define and execute software engineering strategy, architecture direction, staffing and resource plans, and development priorities aligned with company objectives, product roadmaps, and regulatory requirements.
Establish and continuously improve software development processes utilizing Hybrid Agile methodologies and V‑Model SDLC while driving execution excellence, delivery predictability, engineering metrics, and continuous improvement.
Provide oversight for software lifecycle activities including requirements management, architecture, implementation, integration, verification, validation, release management, sustaining engineering, and post‑market software support.
Ensure software development and verification activities comply with applicable medical device regulations, standards, design controls, cybersecurity requirements, and company quality system requirements.
Partner with cross‑functional leaders across Systems, Hardware, Product, Quality, Regulatory, Clinical, Manufacturing, Service, and Operations to support product development, product support, audits, inspections, and regulatory submissions.
Manage software organizations, employees, contractors, offshore development teams, consultants, vendors, and external development partners while fostering accountability, ownership, collaboration, innovation, and quality.
Recruit, develop, mentor, and retain high‑performing engineering leaders and technical staff while building a strong engineering culture focused on accountability, innovation, collaboration, and continuous improvement.
Perform other duties as assigned.