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Associate Systems Engineer
·Israel
HybridFull-timeHardware EngineeringMedical DevicesPackagingPharmaceuticals
Support product development as an Associate Systems Engineer. Characterize system inputs and outputs, develop simulations, author test plans and reports, analyze data, and coordinate vendor testing to ensure compliance with FDA and ISO standards for medical devices.
Responsibilities
- Characterize system and subsystem inputs, outputs, and functionality; develop simulation tools for product specifications and reliability.
- Conduct root cause investigations and trend analysis.
- Generate test setups and work hands-on with various equipment.
- Develop theoretical models and analysis scripts using Matlab, AI tools, etc.
- Author test plans, protocols, and reports for engineering verification.
- Perform data analysis and ensure appropriate techniques and outputs in reports.
- Plan and coordinate testing with external vendors and test labs.
- Collaborate with lead engineers and project managers to meet development schedules.
Requirements
- Bachelor's degree in engineering discipline or equivalent experience.
- 0-3 years of experience.
Nice to have
- Experience with medical device design testing in accordance with FDA regulations.
- Background in R&D/product development with electromechanical devices.
- Six Sigma Green Belt or Black Belt certification.
- Proficiency in MS Office suite.
- Strong technical writing skills and experience writing test plans, protocols, and reports.
- Knowledge of statistics and use of Minitab.
- Knowledge of software code and script development in Matlab, Python, or other tools.
- Knowledge of Quality Management Systems for Medical Devices (ISO 13485), Design Controls (21 CFR 820.30), Risk Management (ISO 14971), Test Method Validation (Gage R&R), and Design Verification/Validation.
- Knowledge of ISO 11608 and IEC 60601-1.