About the Company

This groundbreaking AI SaMD startup is committed to transforming clinical care decision-making and improving patient outcomes globally through state-of-the-art software technologies. The company has already secured regulatory approval and early commercialisation in markets across the globe, and is preparing for FDA clearance and US market entry for their first product. This is an opportunity to enter as the company begins to scale. They are backed by a significant investment partnership and are rapidly accelerating their growth trajectory, so there is potential for you to have huge influence on the success of the company, with plenty of opportunities for personal growth. As our client is preparing for targeted market entry and global market expansion, they are seeking an experience VP of Engineering with a proven track record in SaMD development to join the global executive leadership team.

About the role

As VP of Engineering, you will lead the technical vision and architecture for their AI-powered SaMD platform. You will oversee the entire software development lifecycle, ensuring compliance with medical device standards and regulatory requirements including IEC 62304. You will build and lead high-performing engineering teams, collaborating with Product, Regulatory, and Clinical Affairs to deliver impactful healthcare solutions. This is a role for someone who knows what good SaMD development looks like, can drive strong process and documentation practices, and can drive a lean HealthTech startup team to scale.

The team will rely on you to:

• Define and drive technical strategy, architecture and delivery for the AI-powered SaMD product platform.
• Lead and develop high-performing engineering teams, including software developers, quality engineers, technical support, security, cloud architecture, and corporate IT.
• Ensure compliance with medical device standards (IEC 62304, ISO 13485) and data privacy regulations (HIPAA, GDPR).
• Lead risk management efforts in accordance with ISO 14971 to address safety and usability concerns.
• Lead cybersecurity management processes for company SaMD products
• Collaborate with regulatory and clinical teams for submissions (e.g., FDA 510(k), EU MDR, TGA) and post-market surveillance.

Ideally you have:

• 10+ years of software engineering experience, with 5+ years in a leadership role.
• Experience developing Class II or Class III SaMD products, with strong knowledge of IEC 62304, ISO 13485, and regulatory requirements for medical devices.
• Deep understanding of the software development lifecycle and risk management for SaMD, including cybersecurity principles and standards (e.g., ISO 27001, FDA premarket guidance).
• Experience developing complaint AI/ML models, preferably in healthcare or image processing.
• Working knowledge of healthcare data privacy and security regulations, including HIPAA and GDPR.
• Proven success scaling engineering teams in a startup environment.
• Strong leadership skills with experience “managing up” to executive teams and Board-level stakeholders.

Bonus points if you also have:

• Experience with regulatory processes and submissions (FDA 510(k), EU MDR).
• Experience working with healthcare IT vendors, hospital IT systems, healthcare system integrations, or medical imaging platforms.

What’s next

If you are a strategic leader with a passion for AI-driven healthcare solutions, we encourage you to apply. We will be reviewing applications over the coming weeks, and contacting shortlisted candidates for a phone screen before interviewing with the client.