Engineering Manager - Software as a Medical Device (SaMD)

You will lead a business critical engineering squad responsible for delivering regulated medical AI products in a fast-paced environment. Managing engineers working on AI and SaMD components, you will own the development and delivery of compliant, scalable software that meets stringent medical standards. You’ll bring consistency, speed, and excellence to how the team plans, builds, and ships software.

Key Responsibilities

• Lead engineering delivery for SaMD product roadmap, driving excellent technical execution from the engineers.
• Partner with Product, QA, DevOps, and senior stakeholders to align roadmaps and execution plans.
• Be hands-on when needed, especially in system architecture and solving complex technical issues.
• Manage a growing team by conducting effective 1:1s, coach engineers, lead hiring and onboarding, and manage a career development framework.
• Own IEC 62304 traceability, architecture documentation, and release quality for critical features and audits.
• Establish agile delivery practices that work within the constraints of ISO 13485 and MDR/FDA expectations.
• Introduce best engineering & delivery practices, improve and report on velocity, release cadence, defect rate, and other metrics.
• Champion continuous improvement — lead retros, root cause analysis, and quality initiatives to reduce bugs, unblock teams, and increase predictability.

Have a strong background in:

• Node.js, JavaScript, Express, MySQL, preferably also React.
• Infrastructure & DevOps experience: AWS, Docker, Terraform, Bitbucket, TestRail, Postman.

And proven experience in:

• Leading engineering teams (line managing Seniors and below) in a fast-paced, regulated medical or AI-based software environment, having delivered multiple health tech products.
• Building and delivering clinical software products with end-to-end traceability under IEC 62304 and ISO 13485.
• Driving complex technical decision-making (e.g., architecture reviews, release criteria).
• Leading or supporting regulatory audits and inspections.
• Managing stakeholders across Engineering, Product, QA, and Compliance.
• Implementing metrics and rituals that increase team velocity and delivery consistency.

Behaviours required:

• Communicates clearly at all levels: technical and non-technical.
• Takes ownership of delivery outcomes and team performance.
• Acts fast but never compromises on traceability and regulatory requirements.
• Supports and grows others — builds an inclusive, accountable, high-trust culture.
• Pragmatic — understands our constraints and finds solutions within them.
• Brings structure and consistency to delivery, while adapting to evolving needs.

What success looks like:

• 3 months: Define team rituals that promote alignment, speed, and predictability. Deliver traceability and documentation gap analysis aligned to IEC 62304.
• 6 months: Lead release of a major AI model or SaMD milestone on time. Identify and implement 3 delivery optimisations that improve speed without sacrificing quality.
• 12 months: Expanded the team to support product scaling - hired and onboarded engineers.

Benefits:

• Competitive salary.
• Share options package - all our employees have ownership in the company.
• Private healthcare.
• 25 days annual leave (+ company shut down in August + bank holidays).
• Enhanced parental leave - includes adoption & foster.
• Training budget.
• Besides weekly catch-ups, monthly meetings to talk about you, your ambitions and make plans.
• Lots of fun social activities including company offsite!

The Real Stuff: Skin Analytics embraces and is committed to diversity and equal opportunities. We are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our employees agree to complete their assigned training and diligently follow all company quality management and information security processes.