Electrical Engineering Lead

Must Have Technical/Functional Skills

• 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.

• Six Sigma certification preferred.

• 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.

Salary Range: $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 & amp; Training Reimbursement.

Time Off: Vacation, Time Off, Sick Leave & Holidays.

Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

#LI-SP1

Location

Irvine, CA

Job Function

TECHNOLOGY

Role

Lead

Job Id

415830

Desired Skills

Quality Management | Medical Device NPD

Salary Range

$95,000-$105,000 a year

Desired Candidate Profile

Qualifications : BACHELOR OF COMPUTER SCIENCE