Job Description
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
Animal Researchunmatched
Biomedical Engineeringunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Data Processingunmatched
Design Verificationunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
Hardware Designunmatched
ISO (International Organization for Standardization)unmatched
Integration Testingunmatched
International Electro-Technical Commission (IEC)unmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Medical Protocolsunmatched
Mentoringunmatched
Python Programming/Scripting Languageunmatched
Quality System Requirements (QSR)unmatched
Requirements Managementunmatched
SolidWorksunmatched
System Architectureunmatched
System Integration (SI)unmatched
System Testunmatched
Systems Engineeringunmatched
Technical/Engineering Designunmatched
Test Automationunmatched
Test Designunmatched
Test Fixturesunmatched
Traceabilityunmatched
Verification Plansunmatched
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