Nephrodite
Product Development Engineer – Medical Device
Nephrodite, Atlanta, Georgia, United States, 30383
Overview
Product Development Engineer – Medical Device We are an Atlanta-based startup united in our mission to empower patients with kidney failure and on dialysis toward mobility and freedom through life-enhancing care. We expand the potential of better health and outcomes through science-led, innovative MedTech solutions. We value an inclusive and diverse team, with a culture built on integrity, curiosity, and collaboration. Job Description
The product development engineer will contribute to the development of new technology concepts and prototypes as well as the continuous improvement of existing mechanical and electrical systems. The ideal candidate will have a strong background in electrical engineering, biomedical engineering or related disciplines and will be familiar with medical device design, rapid prototyping and iterative design. You will work as part of our in-house research and development team and interface with our development partners for different aspects of the device. You will observe the dialysis environment, absorb relevant information, help identify device development needs and risks, and manage the execution of assessments and design verifications to drive product development. Roles and Responsibilities
Designing and testing mechanical, electronic and fluidic systems, concept development, and new product development. Work with sensors (optical, electrical, pressure, etc.), microcontrollers and hardware-software interfaces. Maintain meticulous records of experiments, data, and design iterations in compliance with FDA regulations and ISO 13485 design controls. Assess areas of new or added functionality, identify improvements, and plan implementation of changes. Communicate effectively with cross-functional teams involved in device development. Qualifications and Requirements
BSc degree in electrical engineering, computer science, biomedical engineering or related fields. Minimum 3 years of experience, ideally in medical device development; at least two years of experience in sensor selection and integration for medical devices. Relevant Technical Skills
Proficiency in C and/or C++ (embedded firmware) Experience with microcontrollers (ARM Cortex, etc.) or SoCs used in medical devices Experience designing/working with sensors (flow, optical, weight, electrical, pressure, etc.) and understanding of noise, drift, calibration, signal conditioning Experience with stepper motor control Data acquisition and signal processing (filtering, DSP) for sensor signals Hardware-software interfacing: I2C, SPI, UART, ADC/DAC, GPIOs Experience with RTOS (or no-OS) embedded real-time systems Firmware debugging tools: oscilloscopes, logic analyzers, JTAG/SWD PCB/schematic understanding or ability to collaborate with hardware teams Understanding of design controls and risk management (ISO 14971) Regulatory documentation experience (traceability, test protocols, design history files) Knowledge of medical device regulatory standards (FDA 21 CFR Part 820, ISO 13485) Nice to Have
Experience with wireless/BLE/Bluetooth, RF Low power / battery-powered design experience Familiarity with manufacturing, robust design, DFMEA, and process validation Employment Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Medical Equipment Manufacturing Note: This description reflects the primary duties and minimum qualifications for the role. Applications from candidates with related experience are welcome.
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Product Development Engineer – Medical Device We are an Atlanta-based startup united in our mission to empower patients with kidney failure and on dialysis toward mobility and freedom through life-enhancing care. We expand the potential of better health and outcomes through science-led, innovative MedTech solutions. We value an inclusive and diverse team, with a culture built on integrity, curiosity, and collaboration. Job Description
The product development engineer will contribute to the development of new technology concepts and prototypes as well as the continuous improvement of existing mechanical and electrical systems. The ideal candidate will have a strong background in electrical engineering, biomedical engineering or related disciplines and will be familiar with medical device design, rapid prototyping and iterative design. You will work as part of our in-house research and development team and interface with our development partners for different aspects of the device. You will observe the dialysis environment, absorb relevant information, help identify device development needs and risks, and manage the execution of assessments and design verifications to drive product development. Roles and Responsibilities
Designing and testing mechanical, electronic and fluidic systems, concept development, and new product development. Work with sensors (optical, electrical, pressure, etc.), microcontrollers and hardware-software interfaces. Maintain meticulous records of experiments, data, and design iterations in compliance with FDA regulations and ISO 13485 design controls. Assess areas of new or added functionality, identify improvements, and plan implementation of changes. Communicate effectively with cross-functional teams involved in device development. Qualifications and Requirements
BSc degree in electrical engineering, computer science, biomedical engineering or related fields. Minimum 3 years of experience, ideally in medical device development; at least two years of experience in sensor selection and integration for medical devices. Relevant Technical Skills
Proficiency in C and/or C++ (embedded firmware) Experience with microcontrollers (ARM Cortex, etc.) or SoCs used in medical devices Experience designing/working with sensors (flow, optical, weight, electrical, pressure, etc.) and understanding of noise, drift, calibration, signal conditioning Experience with stepper motor control Data acquisition and signal processing (filtering, DSP) for sensor signals Hardware-software interfacing: I2C, SPI, UART, ADC/DAC, GPIOs Experience with RTOS (or no-OS) embedded real-time systems Firmware debugging tools: oscilloscopes, logic analyzers, JTAG/SWD PCB/schematic understanding or ability to collaborate with hardware teams Understanding of design controls and risk management (ISO 14971) Regulatory documentation experience (traceability, test protocols, design history files) Knowledge of medical device regulatory standards (FDA 21 CFR Part 820, ISO 13485) Nice to Have
Experience with wireless/BLE/Bluetooth, RF Low power / battery-powered design experience Familiarity with manufacturing, robust design, DFMEA, and process validation Employment Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Medical Equipment Manufacturing Note: This description reflects the primary duties and minimum qualifications for the role. Applications from candidates with related experience are welcome.
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