Quick overview
Job description
Electrical Engineer – Product Lifecycle Management
Location: Irvine, CA
Experience: 3+ Years
Industry: Medical Devices / Manufacturing
Job Description
We are seeking an experienced Electrical Engineer II to support Product Lifecycle Management (PLM), sustaining engineering, and continuous improvement initiatives for commercially released medical devices and capital equipment.
The ideal candidate will have a strong background in electrical/electronic components, printed circuit board assemblies (PCBAs), component obsolescence, End-of-Life (EOL) assessments, and engineering change management.
The role involves working cross-functionally with R&D, Manufacturing, Supply Chain, Quality, Regulatory Affairs, Operations, and external suppliers to assess lifecycle risks and implement engineering solutions.
Key Responsibilities
Perform technical assessments of electrical/electronic component obsolescence, supplier discontinuance notifications, and EOL risks.
Evaluate impacts on product performance, manufacturing operations, supply continuity, quality, and regulatory compliance.
Support alternate component qualification, second-source validation, redesign activities, last-time-buy recommendations, and inventory strategies.
Execute sustaining engineering and lifecycle management projects with limited supervision.
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 electrical schematics, Bills of Materials (BOMs), PCBAs, and component specifications.
Assess form-fit-function impacts and engineering implementation requirements.
Collaborate with internal stakeholders and external suppliers to evaluate technical alternatives.
Manage project deliverables, schedules, risks, and stakeholder communications.
Ensure compliance with quality systems, design controls, and applicable regulatory requirements.
Required Qualifications
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 (PLM) principles.
Strong analytical, organizational, problem-solving, and communication skills.
Preferred Qualifications
Experience 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/ERP systems.
Experience with medical devices, capital equipment, embedded electronics, or electromechanical systems.
Feel free to let me know if you have any questions or concerns.
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