Senior Hardware Engineer
Who We Areillumicell 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.What You’ll DoDesign & DevelopmentOwn and evolve the hardware system architecture.Translate system requirements into detailed hardware specifications and define design direction.Guide mechanical and electrical design.Integrate internally and externally developed subsystems into a cohesive, validated system.Contribute to design controls, risk management, and regulatory documentation.Device Manufacturing, Testing, & VerificationDefine verification strategy and lead component- and system-level testingAnalyze results, identify root causes, and drive design improvementsSupport manufacturing strategy, pilot builds, and design transfer to productionCollaboration & OversightManage and coordinate external development partners—define deliverables, review designs, and track timelines.Work closely with software, clinical, and regulatory teams to ensure system performance and readiness for submission.What We’re Looking ForBackground & ExperienceProven track record delivering complex hardware systems in MedTech or similarly regulated environmentsHands-on experience with mechanical design (system design, CAD, prototyping) and integration of mechanical, electrical, and software systems.Familiarity with suppliers and manufacturing processes for low- to mid-volume production.Master’s degree in Mechanical, Systems, Robotics, or related engineering field.Technical ExpertiseProficiency in CAD (OnShape, SolidWorks) and revision control practices.Strong understanding of electrical interfaces, system integration, and safety considerations.Experience with verification, validation, and system-level performance testing.Understanding of ISO 14971, IEC 60601, and design control processes.Programming experience (Python, C/C++) is a plusProfileStrategic, hands-on, detail-oriented. Executes fast without compromising quality.Based in Boston, with on-site presence and flexible remote days depending on project needs.Bonus Qualifications (Nice-to-Have)Start-up or scale-up experience.Background in diagnostics, digital pathology, or medical imaging.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: Bring a product to market and change cellular imaging.