Component Engineer

Our Client, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self‑treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre‑mixed dialysate bags or external water‑treatment systems.

We are seeking a Component Engineer to provide targeted support during DVT and design release phases, focusing on component risk reduction, compliance, manufacturability, and documentation quality. This role operates as a technical bridge between Engineering, Supply Chain, and Manufacturing to ensure that component selections and mechanical designs are robust, producible, and aligned with supplier capabilities prior to production release. The position is expected to identify and mitigate risks early, particularly in component selection, tolerancing, and manufacturability, to reduce downstream reliability issues, supply disruptions, and design rework.

• 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.

• 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.
• Support supplier technical discussions.
• Assist in resolving build and early production issues.
• Support supply‑chain activity by identifying long‑lead‑time items and engaging 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/Net Suite.
• Support traceability and audit readiness.

• 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.

• Sitting at a desk utilizing a computer.
• Typical office areas with offices, cubicles and conference rooms.