Product Development Engineer Medical Device (Atlanta)

About Nephrodite

We are an Atlanta based start-up united in our mission to empower patients with kidney failure and on dialysis toward mobility and freedom through life-enhancing care. Through novel and intelligent technology, we expand the potential of better health and health outcomes without constraints or tethers.

We strive to foster an inclusive and diverse team, committed to making a difference. We believe great ideas can come from anywherewe strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our cultureour team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

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 be expected to regularly interface with our development partners for different aspects of the device.We are looking for someone with the ability to keenly observe theESRDenvironment anddialysisecosystem, quickly absorb relevant information, help identifydevice developmentneeds and risks, and manage the execution of assessments and design verifications to drive product development.

Roles And Responsibilities

Roles and responsibilities will include designing and testing mechanical, electronic and fluidic systems, concept development, and new product development, among other areas. Experience with sensors (optical, electrical, pressure, etc), microcontrollers and hardware-software interfaces are a must. You should be a highly organized individual with a demonstrated ability for critical thought and data analysis. You will be required to keep meticulous records of experiments, collected data and device design iterations in compliance with FDA regulations and ISO 13485 design controls. You will be involved in the different aspects of device development, assess areas of new or added functionality for the device, identify areas for improvement and how any changes might be implemented. Effective communication with the respective teams involved with development of the device is required.

Responsibilities and Requirements

BSc degree in electrical engineering, computer science, biomedical engineering or related fields.

• MINIMUM 3 years of experience, ideally in medical device development and at least two years of experience in sensor selection and integration for medical devices

Design Optimization : Conduct iterative design processes to optimize device performance, manufacturability, and compliance with regulatory standards.

Material and Sensor Selection : Evaluate and select appropriate materials for prototypes and final products, considering factors such as biocompatibility, durability, power consumption and cost-effectiveness.

Collaboration : Work closely with cross-functional teams, including R&D, clinical, and manufacturing, to ensure design feasibility and alignment with project goals.

Testing & Verification : Conduct bench-top testing and analysis of prototypes to validate design assumptions and ensure performance specifications are met.

Documentation : Maintain detailed documentation of design processes, prototype iterations, and testing results to support regulatory submissions and intellectual property filings. Understanding of Design Controls and other applicable ISO 13485 guidelines

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.), including understanding characteristics (noise, drift, calibration, signal conditioning)

Experience with stepper motor control

Data acquisition, signal processing (filtering, digital signal processing) when sensor signals are involved

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 or similar

PCB / schematic understanding or ability to collaborate closely with hardware teams (sometimes doing own schematic reviews)

Understanding of design controls, risk management (ISO 14971)

Regulatory documentation experience (traceability, test protocols, design history files)

Knowledge of medical device regulatory standards (e.g. 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 / process validation