Senior Component Engineer

Diality, Inc.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Diality, Inc. is seeking a Sr. Component Engineer to lead component governance across development and manufacturing, ensuring supply continuity and regulatory compliance in a medical device setting.

You will partner with Engineering, Quality, and Supply Chain to manage lifecycle risks, review PCNs, and qualify alternate sources, while driving cost optimization and data integrity in PLM/ERP systems. This role emphasizes cross-functional collaboration, risk mitigation, and sustaining a robust

Qualifications

• Experience working in a regulated medical device environment.
• Ability to assess supply chain risks and mitigation strategies.
• Strong communication and cross-functional collaboration.
• Familiarity with PLM/ERP systems.

Responsibilities

• Partner with Engineering to ensure component selections meet performance and supply continuity.
• Monitor lifecycle status and mitigate obsolescence.
• Support ECOs for additions, substitutions, and PCNs.
• Ensure RoHS/REACH compliance and audit readiness.
• Collaborate across Engineering, Quality, Manufacturing, and Supply Chain.

Skills

Regulatory compliance understanding

Analytical thinking

Project coordination

Independent work

Education

Bachelor’s degree in Electrical, Mechanical, Industrial Engineering, or related technical field

Tools

Propel

NetSuite

Job description

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.

We are seeking a Sr. Component Engineer to lead component engineering activities across product development and manufacturing, with primary responsibility for component governance, risk mitigation, regulatory compliance, and supply continuity. This role partners closely with Engineering, Supply Chain, Quality, and Manufacturing to establish robust component strategies, manage component life-cycle risks, evaluate Product Change Notifications (PCNs), ensure RoHS/REACH compliance, qualify alternate and second-source components, and drive cost optimization initiatives. The position plays a critical role in maintaining a resilient component portfolio that supports uninterrupted manufacturing, regulatory requirements, and long-term product sustainability.

Responsibilities

Component Selection & Design Support

• Partner with Engineering during product development to ensure component selections meet performance, cost, quality, and supply continuity objectives.
• Review new component introductions for technical suitability, approved sourcing, and long-term availability.
• Support design reviews by identifying component-related risks and recommending mitigation strategies prior to design release.
• Support Engineering Change Orders (ECOs) related to component additions, substitutions, and obsolescence.

Component Lifecycle & Risk Management

• Monitor component lifecycle status (Active, NRND, EOL) and proactively identify supply chain risks.
• Develop and implement mitigation strategies, including alternate component qualification and second-source recommendations.
• Evaluate supplier changes, Product Change Notifications (PCNs), and End-of-Life (EOL) notices for business and technical impact.
• Support long-term component strategies to minimize supply disruptions and sustain product availability.

Compliance & Component Governance

• Ensure components comply with applicable regulatory and environmental requirements, including RoHS, REACH, and conflict minerals.
• Maintain approved component specifications, manufacturer information, and sourcing data within PLM and ERP systems.
• Support component standardization initiatives to reduce complexity and improve reuse.
• Maintain component data integrity and support audit readiness.

Supply Chain & Cost Optimization

• Partner with Supply Chain to identify long lead-time components and develop sourcing strategies to improve supply continuity.
• Engage suppliers to evaluate alternate manufacturers, cross-references, and equivalent components.
• Support supplier qualification activities and technical evaluations of new component sources.
• Identify opportunities for component cost reduction through standardization, alternate sourcing, and value engineering.

Cross-Functional Support

• Serve as the primary technical interface between Engineering, Supply Chain, Quality, Manufacturing, and suppliers on component-related matters.
• Support manufacturing and supplier teams in resolving component-related issues during DVT and production builds.
• Participate in cross-functional risk assessments to improve component reliability, availability, and manufacturability.
• Support continuous improvement initiatives related to component management and supply chain resilience.

Data & Documentation Management

• Ensure component documentation, compliance records, and technical specifications are complete prior to product release.
• Support traceability, configuration management, and engineering change activities throughout the product lifecycle.

Requirements

Required Skills & Abilities

• Working knowledge of environmental and regulatory compliance requirements, including RoHS, REACH, and Conflict Minerals.
• Strong analytical and problem-solving skills with the ability to assess technical and supply chain risks and recommend practical solutions.
• Excellent organizational, communication, and project coordination skills with the ability to manage multiple priorities in a fast-paced environment.
• Self-motivated with the ability to work independently while effectively collaborating across cross-functional teams.

Education & Experience

• Bachelor’s degree in Electrical, Mechanical, Industrial Engineering, or related technical field.
• 5+ years of experience in component engineering, hardware engineering, or a related technical role.
• Experience supporting new product development through design, verification, design transfer and manufacturing release.
• Strong understanding of electronic, electromechanical, and mechanical components, including selection, qualification, and application.
• Experience managing components’ lifecycle, including Active, NRND, End-of-Life (EOL), Product Change Notifications (PCNs), and obsolescence mitigation.
• Experience evaluating supply chain risks and developing alternate sourcing and second-source strategies.
• Experience reviewing component datasheets and performing fit, form, and function evaluations for alternate components.
• Experience working with Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems (Propel and NetSuite preferred).
• Experience supporting cross-functional teams including Engineering, Supply Chain, Manufacturing, Quality, and Supplier Quality.
• Experience in a regulated industry, preferable medical devices, with knowledge of ISO 13485 and FDA 21 CFR Part 820/QMS requirements.

Travel

• n/a

Physical Requirements

Sitting at a desk utilizing a computer

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.