Full Time Opening of Mechanical Engineering Lead
Valzo Soft Solutions LLC
Irvine, CA
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JOB DETAILS
SALARY
$95–$100 Per Year
JOB TYPE
Full-time, Employee
SKILLS
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
LOCATION
Irvine, CA
POSTED
Today
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 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
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
About the Company
V
Valzo Soft Solutions LLC
INDUSTRY
Medical Devices and Supplies