Software Lead (MedTech)

illumicell AI; San Francisco (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

illumicell AI is a startup based in San Francisco focused on AI-powered diagnostics. We're seeking a technical leader to manage software system architecture across devices and cloud. The candidate must have strong Python skills, lead teams, and ensure compliance with medical device regulations.

This role involves partner collaborations with product leadership and driving key technical decisions to ensure quality and innovation in our offerings.

Qualifications

• Track record of owning medical device software through at least one FDA or CE submission.
• Deep understanding of IEC 62304, ISO 13485, ISO 14971, and design control processes.
• Experience leading small, high-performing teams and managing external vendors.

Responsibilities

• Own and evolve system architecture across edge devices and cloud.
• Drive and approve key technical decisions.
• Lead external contractors and mentor internal engineers.
• Define and execute software roadmap with the Head of Product.

Skills

Strong Python skills

Knowledge of C++ or Rust

Experience with modern cloud platforms (GCP or AWS)

Leadership in guiding teams

Job description

illumicell AI is a Harvard-Pagliuca Lab based Techmed startup building AI-powered, label-free cell analysis to bring fast, objective diagnostics to the point of care. Starting with male fertility, we’re developing a new standard for how living cells are measured, understood, and acted upon, bridging hardware, software, and machine learning to unlock scalable, real-world clinical impact.

Responsibilities

• Own and evolve the system architecture across edge devices, cloud infrastructure, and lightweight user interfaces.
• Drive and approve key technical decisions.
• Lead external contractors and mentor internal engineers.
• Partner with the Head of Product to define and execute the software roadmap, managing timelines, budgets, and risks.
• Build and enforce CI/CD, automated testing, and code review standards.
• Own system performance, reliability, and cybersecurity across edge and cloud environments.

Design Control & Compliance

Ensure all software development aligns with medical device design controls and regulatory requirements.

What We’re Looking For

Technical Expertise

• Track record of owning medical device software through at least one FDA or CE submission.
• Strong Python skills, plus working knowledge of C++ or Rust.
• Experience with modern cloud platforms (GCP or AWS).

Regulatory Know-How

• Deep understanding of IEC 62304, ISO 13485, ISO 14971, and design control processes.

Leadership

• Experience leading small, high-performing teams and managing external vendors.
• Clear communicator, comfortable working across time zones (core CET hours).

Profile

Strategic, hands-on, detail-oriented. Executes fast without compromising quality.

Nice to Have

• Start-up or scale-up experience.
• Background in diagnostics, digital pathology, or medical imaging.