Company & Job Overview:
Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.
The Senior System Integration Engineer will be responsible for designing, implementing, and managing the integration of sub-system designs in hardware, firmware, and software applications within our medical device system. This role requires a deep understanding of medical device regulations, strong technical skills, and the ability to work collaboratively with different teams to ensure seamless system integration. You will leverage your extensive expertise to drive the design and validation of complex systems, ensuring compliance with regulatory standards and industry best practices.
Responsibilities:
Responsible for coordinating with functional and cross functional team members to ensure project milestones are achieved.
Responsible for strategizing and development of integration test plans to ensure product requirements specifications are met. Coordinate integration testing activities with internal teams and external partners to ensure V&V testing deliverables are met.
Lead the integration testing of hardware sub-systems to ensure seamless interaction and functionality within the overall system.
Oversee and conduct a wide range of tests, including functional, performance, reliability, and environmental tests on complex medical device systems (e.g 60601-1, 60601-1-2, HALT).
Lead investigations into complex technical issues or failures related to hardware/software sub-components. Apply advanced problem-solving techniques, such as root cause analysis (RCA) and failure mode and effects analysis (FMEA), to identify underlying causes and implement robust corrective actions.
Diagnose and troubleshoot complex hardware issues, working collaboratively with cross-functional teams to implement solutions.
Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team.
Qualifications & Requirements:
Bachelor’s or Master’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or a related field.
Minimum of 5-7 years of experience in systems engineering or related field, preferably in medical devices.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization.
Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance.
Expert knowledge on medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.
Proficiency in engineering tools (e.g., SolidWorks, Minitab).
Proficiency in scripting languages (e.g. Python, Matlab) and other software languages.
Proficiency in using test equipment such as oscilloscopes, multimeters, spectrum analyzers, and logic analyzers.
Familiarity with various communication protocols (e.g., I2C, SPI, UART, Ethernet).
Knowledge of hardware design and PCB layout.
Strong problem-solving skills and the ability to conceptualize and develop innovative engineering solutions to complex technical challenges.
Experience in risk management methodologies (e.g., FMEA, fault tree analysis) and their application to medical device development and regulatory compliance.
Proven experience in conducting thorough analysis and evaluation of technical requirements, feasibility, and risks, developing comprehensive engineering solutions and mitigation strategies.
Experience in system architecture design and control system design.
Physical Demands:
Sustained periods of time standing and sitting in a laboratory
Sitting at a desk utilizing a computer
Some lifting of<25 pounds
Working Environment:
Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.
Travel:
Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.
