Job Description

We’re rewriting the rules of fertility and health diagnostics—using sperm as a digital biomarker to unlock insights previously overlooked and considered impossible. Our platform, built on advanced AI and breakthrough cell visualization, is poised to reshape how we understand and treat not just fertility but broader health challenges.

illumicell AI spans Harvard’s Pagliuca Life Lab and Zurich, blending unconventional thinking with scientific rigor. We’ve smashed through archaic methods in diagnostics, and now we need a Head of Product Development to turn our working prototypes into a post-510(k)-cleared, market-ready device that can transform global healthcare.

Location: USA (remote OK) | Employment Type: Full-time

Your Mission: Take a disruptive idea and make it real. Own the product end-to-end—from prototype refinement to FDA clearance—and deliver a category-defining device that will set a new benchmark in fertility and health diagnostics.

• Own the Pipeline: Direct every phase of product design, engineering, and testing. Seamlessly integrate hardware, software, and AI into a single disruptive diagnostic platform.
• Lead FDA 510(k) Clearance: Navigate complex regulatory pathways to ensure we meet U.S. and international standards.
• Prototype to Scale: Drive rapid prototyping and validation, ensuring usability, functionality, and manufacturability at every iteration.
• Collaborate Intensely: Align engineers, AI experts, clinicians, and external consultants toward aggressive product milestones.
• Tackle Obstacles: Face down technical and operational hurdles with relentless focus and creativity.
• Build a Powerhouse Team: Recruit and mentor a world-class product development group capable of conquering a global market.

• Medtech Expertise
• 7+ years of medical device development, ideally in diagnostics.
• Proven success with FDA 510(k) approvals and other regulatory processes.
• Hardware-Software Integration
• Deep experience in system design, hardware engineering, and AI-driven platforms.
• Full lifecycle know-how, from raw prototype to mass production.
• Leadership
• History of leading cross-functional teams and external contractors under tight deadlines.
• Strong project management chops, including budgeting and resource planning.
• Technical Skills
• Background in mechanical, biomedical, or electrical engineering (or equivalent).
• Familiarity with CAD tools, firmware development, ISO standards, and design controls.
• Bonus
• Tenure in top-tier medtech companies (Boston Scientific, Medtronic, etc.).
• AI/ML experience in healthcare.
• Advanced degree in engineering or computer science.

• A hands-on driver of results who thrives in fast-paced environments.
• Obsessed with medtech innovation and fearless about disruptive problem-solving.
• A natural leader with a collaborative spirit and strong communication skills.
• Fueled by the chance to fuse AI, hardware, and healthcare into one revolutionary product.

• Game-Changing Impact: We’re redefining how fertility and broader health diagnostics get done—this is your shot to shape a new global standard.
• Ownership: Lead product development from concept to clearance, championing a pivotal innovation.
• Culture of Boldness: We respect creativity, move fast, and aim high—no idea is off the table.
• Growth & Rewards: Competitive salary, equity, and the chance to be part of a breakout medtech venture.

If you’re ready to push boundaries and shape the next frontier in diagnostics, we want you on board.

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