Senior Medical Device Systems Test Engineer

SoloPoint Solutions, Inc.; Pleasanton (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

SoloPoint Solutions, Inc. is seeking an experienced engineer to design, build, and validate test fixtures for fluidic, mechanical, and optical systems in an endoscopic medical device program.

You will own system-level integration testing, develop verification plans, and write Python scripts for data processing and test automation while collaborating with systems architects and cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering; Master’s or PhD preferred.
• 8+ years of experience in a medical device or similar environment.
• Hands-on expertise with fluidic and vacuum systems, sensors, and data acquisition hardware.
• Proficiency in SolidWorks for fixture and test hardware design.
• Basic Python scripting ability for data processing and device control.
• Familiarity with medical device standards (ISO 13485, FDA QSR, IEC 60601-1).
• Experience with requirements definition, design verification, and traceability documentation.
• Strong communicator who can work independently and cross-functionally in a fast-paced environment.

Responsibilities

• Design, build, and validate test fixtures for fluidic, mechanical, and optical systems from concept through completion.
• Own system-level integration testing for an endoscopic medical device platform.
• Develop and execute verification plans at the system and subsystem level.
• Write basic Python scripts for data processing and test automation.
• Work with systems architects to define and document measurable, testable requirements.
• Support testing using benchtop biologic and ex vivo models; occasional large-animal lab support.
• Mentor junior engineers and serve as a key technical voice in design reviews.

Skills

Fluidic systems

Vacuum systems

Sensors

Data acquisition hardware

Python scripting

Communications

Independent work

Cross-functional collaboration

Requirements definition

Design verification

Traceability documentation

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Master's or PhD preferred

Tools

SolidWorks

Python

Job description

SoloPoint Solutions, Inc. is seeking an experienced engineer to design, build, and validate test fixtures for fluidic, mechanical, and optical systems in an endoscopic medical device program.

You will own system-level integration testing, develop verification plans, and write Python scripts for data processing and test automation while collaborating with systems architects and cross-functional teams in a fast-paced environment.