What are the responsibilities and job description for the Software Lead (MedTech) position at illumicell AI?
Company 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.
Architecture Ownership
Own and evolve the system architecture across edge devices, cloud infrastructure, and lightweight user interfaces.
Drive and approve key technical decisions.
Design Control & Compliance
Ensure all software development aligns with medical device design controls and regulatory requirements.
Team & Vendor Leadership
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.
Strategy & Quality
Build and enforce CI/CD, automated testing, and code review standards.
Own system performance, reliability, and cybersecurity across edge and cloud environments.
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.
French or German.