Software Lead

Ndeva; City of Melbourne; On-site; AUD 180,000 - 230,000; Full time

Job summary

Ndeva in Melbourne is building a portable MR brain scanner for mobile deployment in hospitals. We are seeking the first Software Team Lead to own software end-to-end, set the architecture, and establish IEC 62304 processes to support FDA submission.

You'll lead a small team of embedded Linux and FPGA engineers, make cloud and device architecture decisions, and drive the delivery of the software programme against the clinical roadmap in a regulated medical device environment.

Qualifications

• 10+ years across the stack
• Background in regulated/safety-critical environments
• Real software engineering habits: requirements to architecture, verification strategy, risk analysis
• Experience leading a team

Responsibilities

• Architecture across the whole stack - bare metal, embedded Linux, device UI, cloud
• Standing up IEC 62304 software development processes and verification/risk practice
• Delivery of the software programme against the clinical roadmap
• Technology and cloud platform decisions
• Hiring and leading the software team
• Deciding what work comes in-house from external consultancy

Skills

C++ Linux

Embedded systems

Cloud/AWS

Software architecture

Team leadership

IEC 62304

Regulated environments

DevOps

Tools

AWS serverless

C/C++ bare metal

FPGA

UI touch-screen

DICOM

CI/CD

Python

React/Vue

Job description

A medical device company building a portable magnetic resonance brain scanner, one that gets wheeled to the patient instead of the patient being taken to the scanner.

The first application is acute stroke. When someone arrives in an emergency department with stroke symptoms, a non-contrast CT reliably shows a bleed but not a clot, that needs contrast, which isn't available in every hospital and is harder again after hours. The scanner is used post-CT while the patient is already waiting, so the result reaches the neurologist inside the window where it changes the decision. Today only 1.5% of stroke patients are treated inside that window.

Why they're hiring

The device already works and has been used on patients in a completed feasibility trial at a major Melbourne hospital. What the company doesn't yet have is a software function that can carry an FDA submission.

This is the first Software Team Lead. You'd own software end to end, set the architecture, stand up IEC 62304 for software, and build the team from here.

What you’ll own

• Architecture across the whole stack - bare metal, embedded Linux, device UI, cloud
• Standing up IEC 62304 software development processes, and the verification and risk practice that goes with them
• Delivery of the software programme against the clinical roadmap
• Technology and cloud platform decisions
• Hiring and leading the software team - a cloud/DevOps engineer next, then a second embedded Linux engineer
• Deciding what work comes in-house from the external consultancy

You'd inherit two experienced engineers, one embedded Linux, one FPGA and embedded.

The technical environment

• C++ native Linux applications - the core of the system
• C or C++ on bare metal and a real-time microcontroller
• FPGA in the MR console, covered by an existing engineer
• Python algorithm work that needs porting into production C++
• Touch-screen device UI, used by nurses and technicians
• AWS serverless — Cognito, AppSync, Aurora, DynamoDB, S3, Lambda — with infrastructure-as-code and CI/CD
• Deployed across three regions: US, Australia and Europe
• DICOM for image transfer, with web APIs into third-party clinical systems

Who could be a good fit

Most likely a C++ Linux application developer who has done real embedded work and has dabbled in cloud - you've got your own AWS account, you've built something in React or Vue, you understand how the pieces fit.

You’ll also have:

• 10+ years across the stack, with at least a few in a technical lead or architect role
• A background in a regulated or safety-critical environment — medical devices, aerospace, automotive or industrial machinery
• Real software engineering habits: requirements into architecture, a design that demonstrably meets it, a verification strategy, risk analysis that feeds back into the design
• Experience leading a team — breaking work down, setting direction, and judging whether what comes back is any good

IEC 62304 experience is what they'd most like to see. If your background is heavy avionics or another safety-critical standard, they're comfortable you'll analogise across. Exposure to medical imaging — MRI, CT or X-ray — is a bonus but not required.

The opportunity

A device that already works and has been used on patients, funding through the next clinical milestone, and a software function that is yours to define. You'll have real authority over architecture, platform, process and hiring. And if you haven't taken a device through to FDA before, this is where you do it.