Senior Component Engineer — Medical Devices & Supply Chain

Diality, Inc.; Irvine (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Diality, Inc. is seeking a Sr. Component Engineer to lead component governance and lifecycle management in support of the Moda-flx Hemodialysis system.

You will mitigate risks, ensure regulatory compliance, qualify alternate sources, and drive cost optimization across engineering, supply chain, and manufacturing. The role emphasizes cross-functional collaboration, regulatory knowledge, and sustaining a resilient component portfolio for uninterrupted manufacturing and long-term product

Qualifications

• Bachelor’s degree in Electrical, Mechanical, Industrial Engineering, or related technical field.
• 5+ years in component engineering, hardware engineering, or related technical role.
• Experience in regulated environments, preferably medical devices (ISO 13485, FDA 21 CFR Part 820).
• Experience managing component lifecycles, PCNs, and obsolescence mitigation.
• Familiarity with RoHS/REACH compliance and supplier evaluation.

Responsibilities

• Partner with Engineering to ensure component selections meet performance, cost, quality, and supply continuity objectives.
• Review new components for suitability, approved sourcing, and long-term availability.
• Support ECOs related to components, substitutions, and obsolescence.
• Monitor component lifecycle (Active, NRND, EOL) and identify supply risks.
• Develop mitigation strategies including second-source qualification.
• Interface with Engineering, Supply Chain, Quality, Manufacturing, and suppliers on component matters.

Skills

Regulatory compliance

Analytical abilities

Organizational skills

Cross-functional collaboration

Education

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

Tools

Propel PLM

NetSuite

Job description

Diality, Inc. is seeking a Sr. Component Engineer to lead component governance and lifecycle management in support of the Moda-flx Hemodialysis system.

You will mitigate risks, ensure regulatory compliance, qualify alternate sources, and drive cost optimization across engineering, supply chain, and manufacturing. The role emphasizes cross-functional collaboration, regulatory knowledge, and sustaining a resilient component portfolio for uninterrupted manufacturing and long-term product