Senior Mechanical Engineering Manager

Company & Job Overview:

Diality is a medical device company focused on developing innovative solutions to improve the lives of people 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. Beyond Moda-flx, Diality is developing an ecosystem of care solutions, including Digital Health Technologies, to meet the evolving needs of the modern dialysis landscape.

Diality is seeking a Senior Manager of Mechanical Engineering to lead and develop our mechanical engineering organization and provide technical leadership across the development and lifecycle of our medical device products.

The Senior Manager will be responsible for the technical capability, execution, and growth of the Mechanical Engineering team, while serving as a key engineering leader across the organization. This individual will lead mechanical engineering activities from early concept through commercial launch and sustaining engineering, with responsibility for mechanical architecture, design quality, engineering processes, resource allocation, and cross-functional execution.

The Mechanical Engineering organization supports a broad range of technologies, including water filtration and purification, dialysate generation and delivery, blood handling, electromechanical systems, displays, enclosures, and other critical device subsystems and components.

The successful candidate will be both a technical leader and people leader. They will establish a culture of engineering excellence, develop and mentor a high-performing team, ensure appropriate technical rigor and design practices, and personally engage in the most important technical and architectural decisions. The Senior Manager will partner closely with Systems, Electrical, Software, Manufacturing, Quality, Regulatory, Clinical, and other functions to ensure integrated and effective product development.

Responsibilities:

Technical Leadership

• Provide technical leadership and direction for the Mechanical Engineering organization across new product development, product improvements, and sustaining engineering.

• Establish and maintain strong mechanical engineering practices, methodologies, tools, and design standards.

• Provide technical oversight of mechanical architecture, system-to-subsystem decomposition, requirements, design implementation, and verification.

• Review and challenge major technical decisions and designs to ensure a high standard of engineering quality, reliability, manufacturability, cost, and regulatory compliance.

• Serve as a technical escalation point for complex mechanical engineering problems and critical product issues.

Team Leadership & Development

• Directly manage, mentor, and develop a team of mechanical engineers and designers.

• Build and maintain a high-performing organization through effective hiring, onboarding, coaching, performance management, and retention.

• Assess organizational capabilities and develop plans to address gaps in technical expertise, leadership, and capacity.

• Develop technical leadership within the organization by mentoring Principal and Senior Engineers and other emerging leaders.

• Foster a culture of technical ownership, accountability, collaboration, innovation, and continuous improvement.

Program & Resource Leadership

• Partner with program and functional leaders to establish mechanical engineering priorities, resource plans, schedules, and deliverables.

• Allocate engineering resources across programs based on business priorities, technical risk, and organizational capacity.

• Identify and proactively communicate resource, schedule, technical, and organizational risks.

• Remove organizational and technical roadblocks and ensure the team delivers against commitments.

Cross-Functional Leadership

• Represent Mechanical Engineering on cross-functional product development teams and provide clear technical direction and advocacy for the function.

• Partner with Systems, Electrical, Software, Manufacturing, Quality, Regulatory, Clinical, and other functions to ensure effective product development and integration.

• Ensure mechanical engineering considerations are appropriately represented in product architecture, requirements, risk management, design reviews, verification, and design transfer.

Product Development & Design Controls

• Provide mechanical engineering leadership throughout the product lifecycle, from feasibility and concept development through design transfer, commercial launch, and sustaining engineering.

• Ensure mechanical engineering activities and deliverables comply with applicable design control and regulatory requirements.

• Drive continuous improvement in engineering processes, design quality, cost, reliability, manufacturability, and development efficiency.