Principal Mechanical Engineer

Job Description

Job Description

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 Principal Engineer will lead a cross-functional team in the design and implementation of next-generation hemodialysis blood handling disposable and durable components. This role includes developing and managing the team schedule, directing and tracking the activities of the cross-functional team, and ensuring seamless integration across mechanical, electrical, software, and system design. A key responsibility will be overseeing the mechanical design, which involves both personally contributing to the design and directing an external design group to iteratively refine the product based on requirements and stakeholder feedback. For the durable design, the focus is on electro-mechanical integration and the development of functional prototypes, developing custom injection-molded parts, selecting components and developing the costed BOM. On the disposable side, this role involves developing an innovative blood tubing set, including design, cost, packaging, sterilization, usability, and performance testing.

Responsibilities :

• Leads and contributes to development of company objectives and principles to achieve goals in creative and effective ways.
• Focuses on providing thought leadership and works on broader organization projects, which requires understanding of wider business.
• Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.
• Recognized internally as a subject matter expert. May direct the activities of others.

Qualifications & Requirements :

Experience : Minimum of 12 years of relevant experience, or 8 years with a Master’s degree, or 6 years with a PhD.

Project Leadership : Acts as Workstream Leader for major projects from concept to release, ensuring clear objectives and timely deliverables and reporting. Understands the goals and scope of development.

Hemodialysis Expertise : Hands-on experience with hemodialysis systems, particularly blood handling, dialysis preparation, and delivery.

Reverse Osmosis Expertise : Experience with RO systems, including sediment filters, carbon filters, RO membranes, and mechanical design.

FDA Design Control : Proven experience with the FDA design control process, including documentation of Engineering Inputs, Design Reviews, Design Outputs, Verification Plans, Protocols, Risk Analysis, and DFMEA.

Injection Molding : Successful track record in designing and releasing high-pressure injection-molded parts for production. Experienced in plastic part design, material selection, DFM collaboration, tolerance analysis, first article inspections, and capability studies.

Disposable Blood Handling Sets : Preferred experience in designing and troubleshooting disposable blood handling sets, ensuring functionality, reliability, and regulatory compliance.

Communication and Documentation : Excellent communication, reporting, and documentation skills.

Interdisciplinary Collaboration : Collaborates with systems, electrical and software engineers to develop and improve electro-mechanical components and assemblies for next-generation medical instruments, including pumps, motors, pneumatics, housings, and PCBA mounting.

Mechanical System Analysis : Experience with geometric tolerancing and Finite Element Analysis for structural, fatigue, thermal, vibration, and acoustics analysis.

Product Specifications Development : Participates in the creation of product specifications and requirement documents.

Design Optimization : Designs for reliability, manufacturability, and performance.

Technical Writing : Authors testing plans, engineering test reports, and technical papers using good documentation practices.

SolidWorks Proficiency : A minimum of 2,000 hours of experience working with SolidWorks and PDMWorks is required.

Physical Demands :

Working Environment :

Travel :