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Component Engineer

Job in Irvine, Orange County, California, 92602, USA
Listing for: Katalyst Healthcares & Life Sciences
Full Time position
Listed on 2026-06-18
Job specializations:
  • Engineering
    Mechanical Engineer, Manufacturing Engineer, Quality Engineering, Product Engineer
Job Description & How to Apply Below
Responsibilities:
  • DVT & 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 & 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 & 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.
  • Cross-Functional Support
  • Act as liaison between Engineering and Supply Chain.
  • Support supplier technical discussions.
  • Assist in resolving build and early production issues.
  • Support an effort of the supply chain activity by identifying long lead time items and engaging with the 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/Net Suite.
  • 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 (Net Suite).
  • 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.
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