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 Gantts, 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.

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