Medical Product Development Engineer

About Eyebot

Eyebot is an outcome-focused technology company on a mission to make vision care accessible to everyone, equally. Headquartered in Boston’s North End and backed by top investors and the National Science Foundation, our 90-second vision test kiosk is reshaping how vision care is delivered.

If you’re passionate about solving big problems and building the future of vision care, we’d love to hear from you.

About The Role

We’re looking for a hands-on, detail-oriented Medical Device Product Development Engineer to lead regulatory-compliant product development across our hardware systems. In this role, you’ll ensure our devices meet FDA and IEC 60601-1 requirements, guide safety and quality testing, and help scale our technology from prototypes to commercial systems. You’ll work closely with engineering, product, and operations to translate innovative concepts into robust, field-ready medical devices that meet quality and regulatory standards.

This is a multidisciplinary role for someone who thrives in fast-paced environments and wants to shape the next generation of accessible medical diagnostics.

Note: This is a full-time, in-office role based in Boston. We work together 4-5 days a week to support rapid prototyping and cross-functional collaboration.

What You’ll Do:

• Lead risk analysis, safety reviews, and system testing to support IEC 60601-1 and FDA compliance

• Develop and maintain key QMS documentation (e.g., DHF, DMR, CAPA, verification and validation protocols)

• Coordinate and execute safety and EMC testing with third-party labs (e.g., Intertek)

• Drive implementation of design controls and quality procedures throughout the product lifecycle

• Collaborate with hardware and software teams to ensure system-level safety, reliability, and compliance

• Author and manage documentation for FDA submissions, including labeling, use cases, and instructions for use

• Act as a technical liaison between internal teams, test labs, regulatory consultants, and suppliers

• Support scaling manufacturing processes to meet regulatory and quality requirements

What We're Looking For:

Technical

• 3–7 years of experience developing FDA-regulated medical devices

• Familiarity with IEC 60601-1 (basic safety and essential performance), ISO 14971, and IEC 62366

• Experience working within a QMS in compliance with ISO 13485 or FDA 21 CFR Part 820

• Strong understanding of design controls, risk management, and V&V planning

• Background in mechanical, electrical, or biomedical engineering (or related field)

• Ability to independently lead third-party test engagements and regulatory readiness

• Strong written and verbal communication skills, with a clear documentation mindset

• Highly organized, able to manage cross-functional workstreams and documentation deadlines

• Comfortable working in a hybrid environment with hands-on hardware testing and lab work

Personality

• You’re energized by fast-paced environments and excited to grow with a startup that’s scaling quickly

• You take ownership of your work and care deeply about quality

  • You hold yourself (and your teammates) to a high bar

  • You follow through on commitments and take responsibility for outcomes

• You bring a low ego, collaborative mindset and a sense of humor. You are easy to work with, open to feedback, and able to keep perspective even when things do not go according to plan

Bonus

• Prior experience with Class I or II medical devices

• Experience bringing consumer-facing medical products from prototype to launch

• Familiarity with usability engineering, human factors, and HIPAA compliance

• Knowledge of EMC and electrical safety testing processes

• Exposure to telemedicine or diagnostic imaging devices

What We Offer:

• Flexible work schedule with unlimited PTO

• A culture where every idea is welcome, no matter how out there it sounds — that’s how Eyebot got started

• Full health, dental, and vision insurance

• Commuter support and wellness benefits

• A collaborative office environment in Boston’s North End, with regular team lunches and a great waterfront location

• The chance to build products that improve lives and redefine how vision care is delivered