Senior Systems Engineer

Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

As a Senior Systems Engineer, you will leverage your extensive expertise to drive the design, development, and validation of complex systems, ensuring compliance with regulatory standards and industry best practices.

Responsibilities

• Lead cross-functional team through the design control process.
• Complete DHF documentation deliverables including – Product Requirement Specification, System Architecture Document, System Hazard Analysis, Failure Modes and Effects Analysis
• Collaborates with stakeholders to decompose User Need requirements into product level and subsystem level requirements.
• Lead the risk management process in compliance with ISO 14971
• Strategizes and develops verification and validation test plans to ensure product requirement specifications are met. Coordinates testing activities with internal teams and external partners to ensure V&V testing deliverables are met.
• Develops and validates test methods to appropriately verify product level requirements.
• Actively performs system level verification testing to ensure systems meet product level requirements and standards.
• 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.
• Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team.