Electrical Engineering Lead

Qualifications

• Strong knowledge of theoretical and practical electrical engineering fundamentals, circuit design principles, and experimental engineering techniques.
• Knowledge of Quality Management Systems (QMS) and related tools and methodologies.
• Knowledge of FDA regulations, 21 CFR 211 & 820, ISO 13485, ISO 14971, ISO 17025, and other relevant medical device compliance regulations.
• Understanding of Medical Device Regulatory Standards including MDD/MDR.
• Working knowledge of statistics and Minitab for data analysis.
• Proficiency in electrical CAD/ECAD tools (e.g., Altium Designer, OrCAD, AutoCAD Electrical) to perform design updates and revisions.
• Hands‑on experience creating process flow diagrams, developing project plans using Microsoft Project (Gantt charts), and managing complex project schedules.
• Knowledge of electronic component selection, PCB design and manufacturing, supplier management, product labeling, packaging considerations, 510(k) submission support, project risk management, electrical verification & validation (V&V).
• Ability to prepare and deliver technical presentations to senior management.
• Excellent interpersonal, communication, organizational, and project management skills.
• Understanding of marketing and market research strategies related to electrical/electromechanical products.
• Strong proficiency with Microsoft Office, Microsoft Project, web tools, and spreadsheet and presentation software.
• Qualifications:
  
  BACHELOR OF COMPUTER SCIENCE

• Quality Management | Medical Device NPD

$95,000- $105,000 a year

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage:
  Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support:
  Maternal & Parental Leaves.
• Insurance Options:
  Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth:
  Commuter Benefits & Certification & Training Reimbursement.
• Time Off:
  Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance:
  Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

Irvine, CA

TECHNOLOGY

Lead

415830