Mechanical Engineering Lead

Must Have Technical/Functional Skills

• Must possess knowledge of theoretical and practical fundamentals and experimental engineering techniques.

• Knowledge on Quality Management and its tools & techniques

• Knowledge about FDA, 21CFR211 & 820, ISO 13485, ISO 14971, ISO 17025 and compliance regulations

• Knowledge on Medical Device Regulatory Standards, MDD and MDR

• Knowledge of statistics and Minitab.

• Knowledge of SolidWorks / CAD to perform changes and revise drawings

• Have first-hand knowledge/experience in creating process flow map, developing project plan using MS Project Gantt’s, Organize and Manage individual project plan/schedule

• Six Sigma Certified preferred

• Knowledge on Plastic Molding, Supplier Management, Packaging, Labeling, 510k submission, Project Risk Management, Verification and Validation

• Presentation to Senior Management

• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills

• Understanding of Marketing & market research strategies

• Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web browsers & spreadsheet software

Salary Range: $95,000- $105,000 a year

TCS Employee Benefits Summary:

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

Role: Lead

Desired skills: Quality Management | Medical Device NPD

Qualifications: BACHELOR OF COMPUTER SCIENCE

• Experience: 6 - 20 Years

• Job function: TECHNOLOGY

• Location: Irvine, CA

Salary range: $95,000–$105,000

Apply by: 2026-08-03 00:00:00