Systems Engineer

Job Description

We are seeking a
Systems Engineer with embedded software & electrical systems development experience
to lead the design and integration of advanced digital visualization and illumination systems for
next-generation flexible endoscopic devices
. This is a highly technical, design-focused role centered on embedding
miniature CMOS image sensors, fiber optic bundles, and LED illumination
into millimeter-scale surgical instruments.

The Sr. Design Engineer will serve as the internal subject matter expert on imaging and illumination integration, working closely with electrical, mechanical, and firmware teams to ensure seamless performance and manufacturability of visualization subsystems. This person will play a key role in defining how the device
captures and transmits images from inside the body
, enabling life-saving endoscopic procedures.

This is an exciting opportunity to join a
rapidly growing medical device startup
and help pioneer novel visualization technologies that improve patient outcomes and empower physicians worldwide.

Day-to-Day

• Lead the
  design, development, and integration of CMOS image sensors
  into flexible endoscopic platforms and subsystems.
• Design, prototype, and optimize
  fiber optic and LED illumination
  assemblies for small-form-factor visualization systems.
• Apply
  DFMA principles
  to optical and electronic subassemblies at the millimeter scale, ensuring manufacturability and reliability.
• Develop and layout
  custom PCBs
  for imaging and illumination control using tools such as Altium, KiCAD, or Eagle.
• Create precision CAD models and design
  mechanical fixturing, enclosures, and alignment hardware
  for optical/electronic components.
• Collaborate cross-functionally with
  firmware, mechanical, clinical, regulatory, and manufacturing teams
  to achieve seamless integration and design control compliance.
• Partner with OEMs and suppliers to
  source, validate, and qualify imaging and illumination components
  .
• Support
  verification and characterization testing
  for imaging performance and system reliability.
• Contribute to
  risk management (FMEA), design reviews, and design history documentation
  within an ISO 13485-compliant environment.
• Serve as a
  technical mentor and thought leader
  within the visualization domain as the team scales.

Requirements / Qualifications

Required:

• Bachelor's or Master's degree in
  Electrical, Optical, Biomedical, or Mechatronics Engineering
  (or related field).
• 7+ years
  of engineering experience, ideally in medical devices, imaging systems, or other highly regulated industries.
• Proven hands-on experience integrating
  CMOS image sensors and fiber optic imaging systems
  .
• Strong understanding of
  embedded electronics, firmware interfaces, and signal transmission
  .
• Demonstrated experience with
  LED integration, optical coupling, and miniature illumination systems
  .
• Proficiency with
  PCB design software
  (Altium, KiCAD, or Eagle).
• Proficiency with
  CAD tools
  (SolidWorks preferred) for mechanical design and integration.
• Deep experience applying
  design-for-manufacture/assembly (DFMA)
  principles to small-scale electro-optical assemblies.
• Strong analytical, organizational, and communication skills, with the ability to thrive in a fast-paced startup environment.

Preferred:

• Knowledge of
  ISO 13485, ISO 14971, and FDA QSR
  design control requirements.
• Familiarity with
  IEC 60601
  or other medical device safety standards.
• Experience with
  image signal processing or embedded system design
  .
• Background in
  fiber optics, medical imaging, or surgical visualization systems
  .
• Prior experience in a
  startup or rapid product development environment
  .