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Conduct feasibility studies, simulations, and laboratory testing for device performance and safety.
Ensure all systems are compliant with FDA and other regulatory requirements.
Develop test protocols, analyze data, and document results to validate product performance.
Manage multiple projects simultaneously, ensuring on-time delivery within budget.
Coordinate with internal teams and external vendors for successful project execution.
Troubleshoot and resolve technical challenges related to ultrasound devices, including hardware/software issues, acoustic performance, and user interface.
Identify and implement innovative solutions to enhance device functionality.
Generate and maintain detailed technical documentation, including design history files, risk management plans, and user manuals.
Ensure compliance with medical device regulations, including FDA 510(k) submissions or CE marking requirements.
Minimum 3-5 years of experience in medical device development with a focus on ultrasound technology.
Hands-on experience in transducer design, imaging algorithms, and/or acoustic simulations.
Familiarity with regulatory requirements for medical devices (FDA, CE, ISO standards).
Proficiency in ultrasound imaging principles, signal processing, and acoustic physics.
Experience with CAD software (e.g., SolidWorks), programming (e.g., MATLAB, Python, or C++), and simulation tools (e.g., COMSOL, ANSYS).
Knowledge of embedded systems and hardware/software integration
Ultrasound Engineer
- Posted 24 January 2025
- LocationSan Francisco
- Job type Contract
- Discipline Engineering & CQV
- Reference209995
Job description
About the Role:
We are seeking a highly skilled Medical Device Engineer with a focus on ultrasound systems to join our innovative and dynamic team. The successful candidate will play a critical role in designing, developing, and improving cutting-edge ultrasound medical devices. This position offers the opportunity to work on groundbreaking technologies that directly impact healthcare outcomes.
Key Responsibilities:
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Design and Development:
- Lead the design, prototyping, and development of ultrasound-based medical devices, ensuring compliance with industry standards (e.g., ISO 13485, IEC 60601).
- Develop and optimize transducers, signal processing systems, and imaging algorithms.
- Collaborate with cross-functional teams to integrate hardware, software, and mechanical components into the final product.
Testing and Validation:
Project Management:
Problem Solving:
Documentation and Compliance:
Qualifications:
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Education:
- Bachelor’s or Master’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field. PhD is a plus.
Experience:
Technical Skills: