Mechanical engineering Jobs in Orange, CA

Senior Manager of Mechanical Engineering

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.

Required Skills & Abilities

Engineering Leadership: Demonstrated ability to lead a mechanical engineering organization developing complex electromechanical medical devices.

Mechanical Engineering: Deep expertise in mechanical design, mechanical architecture, and development of complex products.

People Leadership: Demonstrated success managing, mentoring, developing, and retaining engineering talent.

Technical Judgment: Ability to evaluate complex technical problems, identify appropriate solutions, and make sound engineering tradeoffs involving performance, risk, cost, schedule, and manufacturability.

Medical Device Development: Strong understanding of medical device product development and design controls, including requirements, design reviews, risk management, verification, validation, and design transfer.

Design & Manufacturing: Strong knowledge of mechanical design, injection molding, machining, tolerance analysis, GD&T, DFM/DFA, and production processes.

Cross-Functional Leadership: Demonstrated ability to influence and lead across Systems, Electrical, Software, Manufacturing, Quality, Regulatory, and other functions.

Program Execution: Ability to develop resource and technical plans, establish priorities, manage competing demands, and drive execution against commitments.

Engineering Processes: Experience establishing, implementing, and continuously improving engineering processes, methodologies, standards, and tools.

Technical Communication: Excellent written and verbal communication skills, including the ability to communicate complex technical issues and recommendations to senior leadership.

CAD/PDM: Experience with SolidWorks and PDM/PLM systems.

Problem Solving: Demonstrated ability to independently assess complex technical and organizational problems, identify root causes, and drive effective solutions.

Systems Thinking: Ability to understand complex electromechanical systems, define subsystem boundaries, evaluate interfaces, and make sound architectural tradeoffs.

Engineering Organization Development: Ability to assess organizational capabilities, identify technical and leadership gaps, and develop teams and processes to address those gaps.

Preferred Skills & Abilities

Fluid Management Systems: Strong understanding of fluid management technologies, including pumps, valves, tubing, filtration, water purification, and fluidic control systems.

Dialysis Technology: Knowledge of hemodialysis, blood handling, extracorporeal circuits, dialysis fluid preparation, or related medical technologies.

Disposable Medical Devices: Understanding of the design, development, and manufacturing considerations associated with disposable medical device components and fluid pathways.

Change & Growth Leadership: Ability to lead teams through organizational change, evolving product requirements, and a fast-paced development environment.

Education & Experience

Bachelor's or Master's degree in Mechanical Engineering or a related engineering discipline.

Typically 12+ years of relevant engineering experience, including significant experience in medical device product development.

5+ years of demonstrated people leadership and engineering management experience.

Demonstrated experience leading mechanical engineering teams through major product development programs from concept through commercial release.

Demonstrated experience hiring, developing, and retaining high-performing engineering teams.

Experience working within a regulated medical device environment, including familiarity with FDA design controls, ISO 13485, ISO 14971, and applicable medical device standards.

Travel

Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences

Physical Requirements

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.

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.