PERMANENT

FULL_TIME

ADAPTED_NOW

YEAR

Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web browsers & spreadsheet software . Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, the duties and responsibilities for this position are: Lead the CI project by interacting with internal and external stakeholders.

Mechanical Engineering LeadWork Location (State, City and Zip) California, Irvine, 92618Base salary range (Min. & Max. to be mentioned) 95k to 100KExperience Range: A minimum of Technical/Engineering Degree with 6+ years of related experience in Medical Device Product Management domain.<div align="center" style="text-align:center"></div>Must Have Technical/Functional Skills<ul><li>Must possess knowledge of theoretical and practical fundamentals and experimental engineering techniques. </li><li>Knowledge on Quality Management and its tools & techniques </li><li>Knowledge about FDA, 21CFR211 & 820, ISO 13485, ISO 14971, ISO 17025 and compliance regulations </li><li>Knowledge on Medical Device Regulatory Standards, MDD and MDR </li><li>Knowledge of statistics and Minitab </li><li>Knowledge of SolidWorks / CAD to perform changes and revise drawings </li><li>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 </li><li>Six Sigma Certified preferred </li><li>Knowledge on Plastic Molding, Supplier Management, Packaging, Labeling, 510k submission, Project Risk Management, Verification and Validation </li><li>Presentation to Senior Management </li><li>Excellent interpersonal / communication skills, organizational / planning and project management skills </li><li>Understanding of Marketing & market research strategies </li><li>Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web browsers & spreadsheet software </li></ul><div align="center" style="text-align:center"></div>Roles & ResponsibilitiesUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, the duties and responsibilities for this position are:<ul><li>Lead the CI project by interacting with internal and external stakeholders. </li><li>CIP calculation starting from getting quotation from supplier. </li><li>Finalize the budget considering feasibility study, capital investment, validation expense, DVT samples, bioburden etc. </li><li>Create project plan using Microsoft Project and PowerPoint. </li><li>Knowledge of product and functionalities </li><li>Design change or alternative supplier type projects to achieve type II savings. </li><li>Different approach to achieve the CIP. </li><li>Perform testing, writing test protocols, test reports, conduct design review meetings. </li><li>Understand all project activities, time estimation and execution plan </li><li>Understand what tests to perform, getting alignment with R&D. </li><li>Knowledge requirements review, process validation </li><li>Finalizing RR form, review and finalize validation documents. </li><li>Execution of change request and supplier change requests. </li><li>Responsible for communicating business related issues or opportunities to next management level </li><li>Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition </li><li>Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures </li><li>May supervise/lead and provide technical guidance to lower-level personnel </li><li>Performs other duties as assigned </li></ul>Regards, Vivekanand LinkedIn: <a href="https://www.linkedin.com/in/vivekanand0551/" rel="nofollow" style="color:#0563c1;text-decoration:underline">https://www.linkedin.com/in/vivekanand0551/</a>

Valzo Soft Solutions LLC

Full Time Opening of Mechanical Engineering Lead

Budgeting

CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)

Calendar Management

Cartography

Change Requests/Orders

Code of Federal Regulations

Communication Skills

Computer Skills

Corporate Compliance

Corporate Policies

FDA (Food and Drug Administration)

Feasibility Analysis

Federal Laws and Regulations

Green Business

ISO (International Organization for Standardization)

Interpersonal Skills

Investment Capital

Market Research

Marketing

Marketing Strategy

Mechanical Engineering

Medical Equipment

Medical Products

Medical Protocols

Microsoft PowerPoint

Microsoft Project

Microsoft Windows Operating System

Minitab

Molding Processes

Organizational Skills

Presentation/Verbal Skills

Process Development

Process Flow

Process Validation

Product Management

Project Development

Project Planning

Project Schedule

Project/Program Management

Quality Management

Regulations

Regulatory Compliance

Research & Development (R&D)

Risk Management

Safety/Work Safety

Six Sigma Certification

SolidWorks

Spreadsheets

State Laws and Regulations

Statistics

Technical Leadership

Test Plan/Schedule

Testing

Validation Documentation

Validation Testing

Vendor/Supplier Management

Web Browsers

Word Processing

Writing Skills

monster

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