Principal Software Architect – Implantable Medical Device

Mainstay Medical; San Diego (CA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Medical benefits

Dental benefits

Job summary

Mainstay Medical is seeking a Principal Software Engineer to lead the architecture for the ReActiv8 Class III implantable device software. You will direct the software engineering team across embedded firmware, mobile, web, and cloud, ensuring safety, regulatory alignment, and scalable design.

You will collaborate with Product, Quality, and Regulatory to drive architecture decisions, risk assessments, and verification strategies in a highly regulated environment.

Qualifications

• 15+ years of software engineering in product development, including regulated medical devices.

Responsibilities

• Lead the architecture and technical evolution of the ReActiv8 system across embedded firmware, mobile, web, and cloud.
• Define and maintain software architecture strategies, interfaces, data flow, and integration patterns.
• Translate clinical, regulatory, and business requirements into scalable, design‑controlled software.
• Establish architecture frameworks, coding standards, and design reviews.
• Support FDA regulatory submissions and design documentation; participate in audits and inspections.

Skills

Software engineering

Regulated medical devices

IEC 62304

FDA PMA submissions

C#

Azure

GIT

Embedded firmware

Education

Bachelor's degree

Tools

.NET

Blazor

.NET MAUI

EF Core

SQLite

Azure DevOps

Git

Job description

Mainstay Medical is seeking a Principal Software Engineer to lead the architecture for the ReActiv8 Class III implantable device software. You will direct the software engineering team across embedded firmware, mobile, web, and cloud, ensuring safety, regulatory alignment, and scalable design.

You will collaborate with Product, Quality, and Regulatory to drive architecture decisions, risk assessments, and verification strategies in a highly regulated environment.