Senior Component Engineer - MedTech Hardware & Compliance

Diality; Irvine (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Diality is seeking a Sr. Component Engineer to lead component governance and lifecycle risk management for the Moda-flx Hemodialysis System. You will partner with Engineering, Supply Chain, Quality, and Manufacturing to ensure RoHS/REACH compliance, PCN/ECO handling, and supplier qualification.

The role focuses on enabling uninterrupted manufacturing, regulatory compliance, and long-term product sustainability through robust component strategies and cost optimization.

Qualifications

• Bachelor’s degree in engineering or related field.
• 5+ years in component/hardware engineering or related role.
• Experience with PLM/ERP systems (Propel, NetSuite preferred).
• Familiar with RoHS/REACH and regulatory standards.

Responsibilities

• Lead component governance and lifecycle risk mitigation.
• Collaborate with Engineering, Supply Chain and Quality on PCNs and ECOs.
• Maintain RoHS/REACH compliance and supplier qualification activities.
• Identify cost-reduction opportunities through standardization and alternate sourcing.
• Ensure documentation, traceability, and audit readiness for components.

Skills

Regulatory compliance

Risk assessment

Supply chain risk

Analytical thinking

Cross-functional collaboration

Project coordination

Independent work

5+ years experience

Education

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

Tools

Propel

NetSuite

Job description

Diality is seeking a Sr. Component Engineer to lead component governance and lifecycle risk management for the Moda-flx Hemodialysis System. You will partner with Engineering, Supply Chain, Quality, and Manufacturing to ensure RoHS/REACH compliance, PCN/ECO handling, and supplier qualification.

The role focuses on enabling uninterrupted manufacturing, regulatory compliance, and long-term product sustainability through robust component strategies and cost optimization.