What are the responsibilities and job description for the Senior Hardware Engineer position at illumicell AI?
Who We Are
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.
What You’ll Do
Design & Development
- Own 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, & Verification
- Define verification strategy and lead component- and system-level testing
- Analyze results, identify root causes, and drive design improvements
- Support manufacturing strategy, pilot builds, and design transfer to production
Collaboration & Oversight
- Manage 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 For
Background & Experience
- Proven track record delivering complex hardware systems in MedTech or similarly regulated environments
- Hands-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 Expertise
- Proficiency 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 plus
Profile
- Strategic, 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.