Mechanical Engineering Lead

Irvine, CA

$95K/yr – $105K/yrSenior Level

Posted 2 months ago

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Job Summary

Own the project lifecycle with clear process maps, structured scheduling, and executive updates to keep complex programs on track.

  • Process mapping and workflow design to standardize how work flows from concept to delivery.
  • Develop and maintain project plans and Gantt timelines to manage milestones and dependencies.

Job Description

Responsibilities

  • Create process flow map
  • Develop project plan using MS Project Gantt’s
  • Organize and Manage individual project plan/schedule
  • Presentation to Senior Management

Requirements

  • Bachelor of Computer Science
  • Knowledge of SolidWorks / CAD to perform changes and revise drawings
  • Knowledge of statistics and Minitab
  • Knowledge about FDA, 21CFR211 & 820, ISO 13485, ISO 14971, ISO 17025 and compliance regulations
  • Knowledge of Medical Device Regulatory Standards, MDD and MDR
  • Knowledge of Microsoft Project / MS Project Gantt’s, Organize and Manage individual project plan/schedule

Preferred

  • Six Sigma Certified preferred

Benefits

  • 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.