Need: Project Lead (Electrical Engineering) for Irvine, CA

Job Title: Senior Electrical Engineering Project Lead – Medical Devices
Location: Irvine, CA
Duration: 12+ Months

Job Summary

We are seeking a highly experienced Senior Electrical Engineering Project Lead with a strong background in Medical Device R&D, Electrical Systems Design, Regulatory Compliance, and Project Management. The ideal candidate will lead Continuous Improvement Projects (CIP), manage cross-functional teams, support product design enhancements, and drive engineering initiatives within a regulated medical device environment.

Required Experience

• 8+ years of Electrical Engineering experience, preferably in the Medical Device industry.
• Experience leading engineering projects involving product design changes, supplier transitions, and cost reduction initiatives.
• Strong understanding of product lifecycle management, risk management, and design controls.
• Experience working in highly regulated environments.

Must-Have Technical Skills

Electrical Engineering

• Electrical Circuit Design
• Electrical Systems Engineering
• Analog & Digital Electronics
• Electronic Component Selection
• Electrical Verification & Validation (V&V)
• Design Reviews and Engineering Testing
• Product Architecture and System Design

PCB Design & ECAD Tools

• PCB Design
• Altium Designer
• OrCAD
• AutoCAD Electrical
• ECAD Design Updates and Revisions
• Manufacturing Support

Medical Device Compliance & Regulatory

• FDA Regulations
• 21 CFR Part 211
• 21 CFR Part 820
• ISO 13485
• ISO 14971
• ISO 17025
• MDD (Medical Device Directive)
• MDR (Medical Device Regulation)
• Quality Management Systems (QMS)
• Design Controls
• Risk Management
• Validation Documentation
• 510(k) Submission Support

Data Analysis & Statistics

• Minitab
• Statistical Analysis
• Engineering Data Interpretation
• Process Capability Analysis

Project & Process Management

• Microsoft Project
• Gantt Chart Development
• Project Planning & Scheduling
• Budget Planning
• Cost Reduction Programs
• Continuous Improvement Projects (CIP)
• Supplier Management
• Change Control Management

Key Responsibilities

Project Leadership

• Lead Continuous Improvement Projects (CIP) in collaboration with internal teams and external suppliers.
• Drive engineering initiatives focused on product optimization, cost reduction, and performance improvements.
• Manage project scope, schedules, budgets, and resource allocation.

Engineering & Product Development

• Lead design modifications, component substitutions, and supplier transitions.
• Evaluate product electrical designs, architecture, and system functionality.
• Develop innovative solutions to achieve project and business objectives.
• Support product enhancements and lifecycle management activities.

Testing & Validation

• Develop test protocols and test plans.
• Execute engineering testing and verification activities.
• Prepare technical reports and validation documentation.
• Conduct design reviews and risk assessments.

Regulatory & Quality Compliance

• Ensure compliance with FDA regulations and international quality standards.
• Support process validation and documentation activities.
• Participate in change control and supplier qualification processes.
• Review and approve engineering and quality documentation.

Supplier & Cost Management

• Evaluate supplier quotations and cost-saving opportunities.
• Support supplier qualification and transition activities.
• Manage engineering aspects of sourcing initiatives.

Cross-Functional Collaboration

• Work closely with:
  • R&D Teams
  • Quality Engineering
  • Regulatory Affairs
  • Manufacturing Operations
  • Supply Chain Teams
• Serve as the technical liaison between stakeholders and project teams.

Leadership Responsibilities

• Provide technical guidance to junior engineers and technicians.
• Participate in technical team selection and resource planning.
• Monitor project performance and ensure delivery commitments are met.
• Lead phase reviews, business reviews, and project status meetings.
• Prepare and deliver technical presentations to senior leadership.
• Support progression toward larger multi-disciplinary project leadership responsibilities.

Preferred Qualifications

• Six Sigma Certification (Green Belt or Black Belt preferred).
• PMP Certification preferred.
• Experience with Lean Manufacturing methodologies.
• Strong understanding of product labeling and packaging requirements.
• Experience supporting 510(k) submissions.
• Knowledge of bioburden testing and validation processes.

Required Soft Skills

• Strong Communication and Presentation Skills
• Stakeholder Management
• Project Leadership
• Analytical Thinking
• Problem Solving
• Organizational Skills
• Team Collaboration
• Technical Documentation

Experience Required

8+ Years

Preferred Industry Experience

• Medical Devices
• Healthcare Technology
• Life Sciences
• Regulated Manufacturing

---
Thanks & Regards
Ishita Bali
Novia Infotech LLC
4421 Avenida Ln, McKinney, TX 75070
Email: ishita.b@noviainfotech.com

--
You received this message because you are subscribed to the Google Groups "NoviaJobs" group.
To unsubscribe from this group and stop receiving emails from it, send an email to noviajobs+unsubscribe@googlegroups.com.
To view this discussion visit https://groups.google.com/d/msgid/noviajobs/CAGiqXEAUj%3DEZZdCy3-oiD4aER6jxHtfkZKqdEYQ8obXTik0N%3Dw%40mail.gmail.com.