Who We Are

illumicell AI turns live-cell imaging at the point of care into a versatile digital-biomarker platform. Developed in our Zurich R&D hub and refined at Harvard’s Pagliuca Life Lab, our AI-driven system began by redefining sperm analysis and now aims to bring the same real-time precision to any cell—blood, immune, or environmental—delivering on-the-spot diagnostic insights where they matter most.

We’re now looking for an experienced Software Lead to own software architecture, development processes, and regulatory compliance as we drive toward FDA 510(k) submission.

Your Mission

Guide the end-to-end development of our software platform—edge devices, cloud services, and interfaces—while ensuring every line of code is traceable, testable, and submission-ready.

What You’ll Do

Architecture Ownership:

• Define and evolve system architecture across edge controllers, cloud micro-services, and lightweight UIs.
• Approve major design and implementation decisions; set coding standards and DevOps strategy.

Design Control & Compliance:

• Lead software risk management and verification/validation under IEC 62304, ISO 13485, ISO 14971.
• Prepare and maintain technical documentation for FDA 510(k) and EU MDR submissions.
• Ensure data privacy and security (GDPR, HIPAA).

Team & Vendor Leadership:

• Manage external contractors and mentor internal developers.
• Develop the software roadmap with the Head of Product; track budgets, timelines, and risks.

DevOps & Quality:

• Establish CI/CD pipelines, automated testing, and code-review culture.
• Monitor performance, reliability, and cybersecurity of edge and cloud systems.

What We’re Looking For

Technical Expertise:

• Proven ownership of medical-device software through at least one FDA or CE submission.
• Proficiency in Python and working knowledge of C++/Rust plus cloud platforms (GCP or AWS).

Regulatory Know-How:

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

Leadership Skills:

• Experience managing small, cross-functional teams and external vendors.
• Excellent communication in English; able to work core CET hours.

Soft Skills:

• Strategic thinker, proactive, detail-oriented, and strong problem-solver.

Bonus Qualifications (Nice-to-Have):

• Start-up or scale-up experience.
• Background in diagnostics, digital pathology, or imaging.
• French or German language skills.

Why Join illumicell AI?

• Innovative Impact: Contribute to groundbreaking healthcare technology that transforms fertility diagnostics.
• Dynamic Team Culture: Be part of an interdisciplinary, collaborative, and supportive team at the cutting edge of health tech and AI.
• Growth Opportunities: Build and lead the software function from the ground up.