Quick overview
Job description
Electrical Test Engineer || Location – Irvine, CA || Employment type - Full Time Direct Hire
Job Description
Exp : 3+ Years
Industry : In Manufacturing, Medical Devices, or Regulated Industry.
Job Summary:
The Electrical Engineer II, Product Lifecycle Management supports the sustainment and continuous improvement of commercially released medical devices and capital equipment.
This role evaluates electrical component obsolescence, performs End-of-Life (EOL) assessments, and implements engineering solutions that support product availability, manufacturing continuity, quality, compliance, and business objectives.
The position works with R&D, Manufacturing, Supply Chain, Quality, Regulatory Affairs, Operations, and suppliers to assess lifecycle risks, execute engineering changes, and support business continuity for electrical systems and printed circuit board assemblies (PCBAs).
Key Responsibilities:
- Perform technical assessments of electrical and electronic component obsolescence, supplier discontinuance notifications, and EOL risks.
- Evaluate impacts to product performance, manufacturing operations, supply continuity, quality, and regulatory compliance.
- Support mitigation plans, including alternate component qualification, second-source validation, redesign activities, last-time-buy recommendations, and inventory strategies.
- Execute assigned lifecycle management and sustaining engineering projects with limited supervision, escalating complex issues when appropriate.
- Investigate and resolve moderately complex issues related to quality, reliability, manufacturability, cost, and component availability.
- Author and implement engineering changes, including impact assessments, risk evaluations, verification and validation activities, and documentation updates.
- Review schematics, bills of materials, PCBAs, and component specifications to assess form-fit-function impacts and implementation requirements.
- Coordinate with internal stakeholders and external suppliers to evaluate technical alternatives and implement practical solutions.
- Manage assigned deliverables, schedules, risks, and actions, and communicate status to project teams and stakeholders.
- Contribute to continuous improvement while maintaining compliance with applicable quality systems, design controls, and regulatory requirements.
Qualifications Required:
- Bachelor's degree in Electrical Engineering or a related engineering discipline.
- Minimum 3 years of relevant engineering experience in manufacturing, medical devices, or another regulated industry.
- Experience with electronic components, PCBAs, electrical systems, schematics, and engineering documentation.
- Knowledge of engineering change processes and product lifecycle management principles.
- Strong analytical, organizational, problem-solving, and communication skills.
Preferred:
- Experience supporting released products in sustaining engineering, technical stewardship, or lifecycle management.
- Experience with component obsolescence analysis and EOL assessments.
- Familiarity with ISO 13485, ISO 14971, FDA quality requirements, and design controls.
- Experience with Windchill, SAP, or similar PLM and ERP systems.
- Experience with medical devices, capital equipment, embedded electronics, or electromechanical systems.
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