Senior Component Engineer - DVT & Design Release

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 135,000; Full time

Job summary

Katalyst CRO in Irvine, CA seeks an experienced Component Engineer to drive DVT readiness and design release for electronic and electromechanical components. You will assess lifecycle risk, coordinate with Engineering and Supply Chain, and ensure manufacturability and compliant documentation for pre-production readiness.

Responsibilities include reviewing drawings, providing DFM/DFA feedback, and supporting supplier discussions while aligning data across Propel and NetSuite.

Qualifications

• Bachelor's degree in Electrical or Mechanical Engineering or related technical field.
• 5+ years of component/hardware engineering experience.
• Experience supporting product development through DVT and design release.
• Experience in regulated environment (medical device preferred).
• Hands-on cross-functional collaboration with Engineering, Supply Chain and Manufacturing.
• Strong understanding of electronic, electromechanical, and mechanical components.
• Experience evaluating component lifecycle (Active, NRND, EOL) and supply risk.
• Ability to read datasheets and perform fit, form, and function analysis.
• Ability to review mechanical drawings and GD&T.
• Familiarity with PLM systems (Propel) and ERP systems (NetSuite).
• Understanding of ISO 13485 and FDA 21 CFR Part 820 preferred.
• Strong analytical and problem-solving skills with attention to detail.

Responsibilities

• DVT readiness and design release support.
• Participate in DVT readiness and design reviews to identify component risks, manufacturability concerns, and documentation gaps.
• Support design transfer activities to ensure readiness for manufacturing release.
• Component risk and lifecycle assessment.
• Evaluate lifecycle status (NRND/EOL), supplier risk, and availability.
• Recommend alternates and mitigation strategies.
• Support release of OTS and custom parts.
• Mechanical drawing review and manufacturability.
• Review drawings for dimensional accuracy, GD&T, and tolerance stack-up risks.
• Assess manufacturability relative to supplier capabilities.
• Identify over-constrained tolerances and yield risks.
• Provide actionable DFM/DFA feedback.
• Cross-functional support.
• Act as liaison between Engineering and Supply Chain.
• Support supplier technical discussions.
• Assist in resolving build and early production issues.
• Identify long lead time items and engage with suppliers for cross-references.
• Lifecycle advancement of components in Propel with complete specifications, compliance and approved sourcing for pre-production readiness.
• Ensure alignment of component data across Propel/NetSuite.
• Support traceability and audit readiness.

Skills

DVT readiness

Design transfer

Lifecycle assessment

GD&T ASME Y14.5

DFM/DFA feedback

Cross-functional collaboration

PLM Propel familiarity

NetSuite familiarity

Regulatory awareness

Analytical problem solving

Education

Bachelor's degree in Electrical/Mechanical Engineering

Tools

Propel PLM

NetSuite ERP

Job description

Katalyst CRO in Irvine, CA seeks an experienced Component Engineer to drive DVT readiness and design release for electronic and electromechanical components. You will assess lifecycle risk, coordinate with Engineering and Supply Chain, and ensure manufacturability and compliant documentation for pre-production readiness.

Responsibilities include reviewing drawings, providing DFM/DFA feedback, and supporting supplier discussions while aligning data across Propel and NetSuite.