Full Time Opening of Mechanical Engineering Lead

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

Mechanical Engineering Lead

Work Location (State City and Zip)
California Irvine 92618

Base salary range (Min. & Max. to be mentioned)
95k to 100K

Experience Range:
A minimum of Technical/Engineering Degree with 6 years of related experience in Medical Device Product Management domain.

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

Roles & Responsibilities

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.
CIP calculation starting from getting quotation from supplier.
Finalize the budget considering feasibility study capital investment validation expense DVT samples bioburden etc.
Create project plan using Microsoft Project and PowerPoint.
Knowledge of product and functionalities
Design change or alternative supplier type projects to achieve type II savings.
Different approach to achieve the CIP.
Perform testing writing test protocols test reports conduct design review meetings.
Understand all project activities time estimation and execution plan
Understand what tests to perform getting alignment with R&D.
Knowledge requirements review process validation
Finalizing RR form review and finalize validation documents.
Execution of change request and supplier change requests.
Responsible for communicating business related issues or opportunities to next management level
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
Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
May supervise/lead and provide technical guidance to lower-level personnel
Performs other duties as assigned

Regards
Vivekanand

LinkedIn:

Mechanical Engineering Lead Work Location (State City and Zip) California Irvine 92618 Base salary range (Min. & Max. to be mentioned) 95k to 100K Experience Range: A minimum of Technical/Engineering Degree with 6 years of related experience in Medical Device Product Management domain. Must Have T...