Optics & Imaging Hardware Engineer

Location: Baltimore, MD 
Job Type: Full-Time 
Start Date: Immediate 
Compensation: $75,000 - $110,000, commensurate with experience 

About the Role

We’re hiring an Optics & Imaging Hardware Engineer who can own the full lifecycle of our imaging hardware and thrive in a fast-paced startup environment. You’ll lead the testing and manufacturing of our current smartphone eye imaging system, support regulatory clearance activities, and lead design and prototyping of future technologies for accessible, portable eye exams. You’ll navigate regulatory requirements, optimize for manufacturing, and ensure clinical-quality performance, while also driving R&D on new product ideas. If you’re motivated by improving healthcare globally and excited to translate innovative optical and hardware solutions into devices that can prevent blindness for millions, this role is for you. 

Key Responsibilities 

• Product Development & R&D 

• Lead hardware design and development for Visilant’s smartphone-based eye imaging systems for portable, ophthalmic exams 

• Own the full product lifecycle from concept design through prototyping, testing, manufacturing, and regulatory clearance. 

• Design, test, and refine optical systems to achieve clinical-quality imaging in compact, cost-effective hardware. 

• Design for Manufacturing 

• Lead design-for-manufacturing (DFM) and transfer to contract manufacturers. 

• Manage contractors, supplier relationships, evaluate prototypes, and oversee quality control processes. 

• Regulatory & Compliance 

• Support the FDA 510(k) process and other international regulatory submissions. 

• Ensure compliance with medical device standards (ISO 13485, IEC 60601, biocompatibility, electrical safety, etc.) 

• Prepare documentation for design history files (DHFs), technical files, and risk management. 

• Testing & Verification 

• Develop and execute verification and validation testing protocols. 

• Collaborate with clinical partners to ensure devices meet performance and usability requirements. 

Minimum Qualifications 

• Bachelor’s degree in Biomedical, Electrical, or Mechanical Engineering, or related field. 

• 3+ years of hands-on experience developing hardware products, ideally in medtech or imaging. 

• Strong background in optics, optical system design, and imaging technologies. 

• Experience with design-for-manufacturing and working with contract manufacturers. 

• Familiarity with medical device regulatory requirements (FDA, ISO 13485, IEC standards). 

• Proficiency in CAD tools and optical design software (e.g., SolidWorks, Zemax/OpticStudio, COMSOL). 

Preferred Qualifications 

• Advanced degree in Biomedical, Electrical, or Mechanical Engineering, or a related field. 

• Experience leading a hardware product from concept through FDA 510(k) clearance. 

• Track record of publications, patents, or product launches in optical or medical device fields. 

• Previous experience in a startup or global health setting. 

Why Join Us? 

At Visilant, you'll join a passionate, high-performing team of engineers, clinicians, and entrepreneurs building technology that delivers life-changing care to millions. We're an early-stage, mission-driven company with the traction and partnerships to drive global impact. 

• Advance and develop impactful imaging systems: Take a project from concept to regulatory approval. 

• Learn and grow across disciplines: Gain hands-on experience in optics, mechanical/electrical design, manufacturing, and regulatory compliance in a startup environment. 

• Improve lives at scale: Our platform is poised to increase access to eye care to millions of patients.