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Electrical Engineer II - Medical Devices
HonorVet Technologies
- 🇺🇸 United States
- On-site
- 13 hours ago
- $40 – $50 / hour
- Regulatory Compliance
- Windchill
- SAP
- ERP
- Change Management
13 hours ago
Job Title: Electrical Test Engineer II
Job Location: Irvine, CA
Job Duration:12 Months
Job Summary:
- At client, we are driven by the meaningful work we do to help people see brilliantly. 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).
- 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.
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.
- 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.
- Product Lifecycle Management
- Component Obsolescence & EOL Assessment
- Sustaining Engineering
- Engineering Change Management
- Risk Assessment
- Electrical Systems & PCBA Fundamentals
- Project Execution
- Cross-Functional Collaboration
- Continuous Improvement
Electrical Engineer II - Medical Devices · HonorVet Technologies