- 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(1)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 2 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.
- Component Obsolescence & EOL Assessment
- Electrical Systems & PCBA Fundamentals
Electrical Test Engineer in irvine at Unknown Company
This position is listed as full time and onsite.