Sr Systems Test Engineer

SoloPoint Solutions, Inc.

Pleasanton, CA

JOB DETAILS
SKILLS
Animal Research, Biomedical Engineering, Communication Skills, Cross-Functional, Data Processing, Design Verification, Documentation, FDA (Food and Drug Administration), Hardware Design, ISO (International Organization for Standardization), Integration Testing, International Electro-Technical Commission (IEC), Mechanical Engineering, Medical Equipment, Medical Protocols, Mentoring, Python Programming/Scripting Language, Quality System Requirements (QSR), Requirements Management, SolidWorks, System Architecture, System Integration (SI), System Test, Systems Engineering, Technical/Engineering Design, Test Automation, Test Design, Test Fixtures, Traceability, Verification Plans
LOCATION
Pleasanton, CA
POSTED
30+ days ago
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

 

About the Company

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SoloPoint Solutions, Inc.