Component Engineer

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Irvine, California is seeking a skilled Component Engineer. In this role, you will participate in design reviews and support design transfer activities ensuring manufacturing readiness. Ideal candidates possess a Bachelor's degree in Engineering and have over 5 years of relevant experience.

The successful candidate will work closely with cross-functional teams and must be familiar with GD&T, PLM and ERP systems. This position is critical in identifying component risks and supporting product development processes.

Qualifications

• 5+ years of experience in component engineering, hardware engineering, or a related technical role.
• Excellent understanding of GD&T principles (ASME Y14.5).
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 requirements preferred.

Responsibilities

• Participate in DVT readiness and design reviews to identify component risks.
• Support design transfer activities to ensure readiness for manufacturing release.
• Act as liaison between Engineering and Supply Chain to support collaboration.

Skills

Component engineering

Mechanical drawing review

DFM/DFA feedback

Cross-functional collaboration

Problem-solving skills

Education

Bachelor degree in Electrical, Mechanical Engineering, or related technical field

Tools

PLM systems (Propel)

ERP systems (NetSuite)

Job description

Responsibilities

• 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.
• Evaluate lifecycle status (NRND/EOL), supplier risk, and availability.
• Recommend alternates and mitigation strategies.
• Support release of OTS and custom parts.
• Mechanical drawing review & manufacturability: review drawings for dimensional accuracy, GD&T (ASME Y14.5), and tolerance stack‑up risks.
• Assess manufacturability relative to supplier capabilities.
• Identify over‑constrained tolerances and yield risks.
• Provide actionable DFM/DFA feedback.
• Act as liaison between Engineering and Supply Chain to support cross‑functional collaboration.
• Support supplier technical discussions.
• Assist in resolving build and early production issues.
• Identify long lead‑time items and engage with suppliers for potential cross‑references.
• Support lifecycle advancement of components in Propel by ensuring complete specifications, compliance, and approved sourcing for pre‑production readiness.
• Ensure alignment of component data across Propel/NetSuite.
• Support traceability and audit readiness.

Requirements

• Bachelor degree in Electrical, Mechanical Engineering, or related technical field.
• 5+ years of experience in component engineering, hardware engineering, or a related technical role.
• Experience supporting product development through DVT and design release phases.
• Experience in a regulated environment (medical device preferred).
• Hands‑on experience working with cross‑functional teams (Engineering, Supply Chain, Manufacturing).
• Strong understanding of electronic, electromechanical, and mechanical components.
• Experience evaluating component lifecycle (Active, NRND, EOL) and supply risk.
• Ability to review datasheets and perform fit, form, and function analysis.
• Ability to read and critically review mechanical drawings.
• Working knowledge of GD&T (ASME Y14.5) principles.
• Understanding of tolerance stack‑up and its impact on assembly and performance.
• Familiarity with common manufacturing processes (machining, molding, sheet metal) and associated constraints.
• Familiarity with design transfer processes and production ramp considerations.
• Familiarity with PLM systems (Propel) and ERP systems (NetSuite).
• Understanding of ISO 13485 and FDA 21 CFR Part 820 requirements preferred.
• Strong analytical and problem‑solving skills with attention to detail.
• Ability to identify risks and provide clear, actionable recommendations.
• Effective communication across engineering and operations teams.
• Ability to work independently in high‑impact role with minimal supervision.
• Strong organizational skills and ability to prioritize high‑value activities.

Physical Demands

• Sitting at a desk utilizing a computer.

Working Environment

• Typical office areas with offices, cubicles and conference rooms.