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Job Details

Skills

Engineering Management
Test Plans
Electromechanics
Research and Development
Exploratory Testing
Computer Hardware
Documentation
Manufacturing
Regulatory Compliance
Data Analysis
Analysis Of Variance
Communication
Electrical Engineering
Biomedicine
Quality Assurance
Medical Devices
ISO 13485
ISO 9000
Risk Management
Verification And Validation
Management
Writing
IQ
OQ
PQ
Test Methods
MATLAB
Minitab
Test Equipment
Sensors
Testing
SolidWorks
Mechanical Engineering
Data Acquisition
Python
C
Schematics
Rapid Prototyping
SLA
FDM

Engineering Management
Test Plans
Electromechanics
Research and Development
Exploratory Testing
Computer Hardware
Documentation
Manufacturing
Regulatory Compliance
Data Analysis
Analysis Of Variance
Communication
Electrical Engineering
Biomedicine
Quality Assurance
Medical Devices
ISO 13485
ISO 9000
Risk Management
Verification And Validation
Management
Writing
IQ
OQ
PQ
Test Methods
MATLAB
Minitab
Test Equipment
Sensors
Testing
SolidWorks
Mechanical Engineering
Data Acquisition
Python
C
Schematics
Rapid Prototyping
SLA
FDM

Summary

Position Summary

The Test Engineer designs, builds, and validates test methods for verification and validation testing for medical devices and disposables in an ISO 13485 and FDA QSR compliant environment. This Role reports to Quality or Engineering Management, supporting various project teams in different stages of project maturity from R&D through Production.

Key Responsibilities

Verification Testing: Plan and execute Design Verification and Validation activities for com plex electromechanical devices and single-use disposables
Test Method Development: Design, develop, validate and execute test methods to inform design decisions and verify system functionality
Research & Development: Conduct early-stage exploratory testing and characterization to support design inputs
Equipment Development: Design, fabricate, and assemble custom test fixtures and automated equipment
Equipment Validation: Write and execute protocols and reports for test software and hardware
Documentation: Author test protocols, data sheets, and final reports. Author/assist manufacturing procedures, machine instructions
Quality Compliance: Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards
Data Analysis: Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets
Communication: Present test findings to relevant stakeholders, communicate risk and countermeasure insights as applicable

Required Qualifications
- Education: Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience
- Experience: 2-5 years of engineering experience within the medical device or regulated industry
- Regulations: Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards
- Verification & Validation: Direct experience in planning and execution of Verification and Validation for complex electrotechnical devices
- Validation Skills: Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV)
- Technical Tools: Proficiency with data acquisition systems, and proficiency in analysis tools like MATLAB, or statistical software like Minitab
- Lab Skills: Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors
Preferred Qualifications
- Experience with endoscopic surgical laser systems
- Experience with surgical fluid irrigation/aspiration systems and components (pumps, pressure sensors, flow sensors)
- Experience testing polymer-based fluid delivery components or single-use medical disposables (biocompatibility, sterilization validation)
- SolidWorks or CAD proficiency for mechanical fixture design
- Experience coding data acquisition using Python / C, able to troubleshoot basic code
- Able to read schematics
- Experience with rapid prototyping (SLA, FDM, CNC)

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10109239
Position Id: cc1286b1db1d9f7c1069bfa78b47db21
Posted 2 days ago

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