Project Manager

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
  
  

Experience Required

• Strong Experience in Quality Management Systems (QMS).
• Experience working in various acquisition, integration, and divestiture activities
• Work experience in the Medical Device industry.
  
  

Responsibilities

Roles & ResponsibilitiesUnder (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Lead the CIP 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 power point.
• 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.
• Understanding on all the project activities, time estimation and execution plan
• Understanding of what test 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 assigned as needed
  
  

Generic Managerial Skills

• Take part in making decisions on selection of suitable team based on the project needs in concurrence with the customer
• Meet delivery promise in terms of budget and timescales
• Monitor project progress and team performance and make necessary changes to the team as needed to ensure achievement of project goals
• Work within a multi-discipline team
• Liaison with customer designated point of contact and functional area point of contact
• Responsibility for team and cross-functional communications; lead phase and business reviews, project meeting minutes, issues log, metrics, and other key communications
• Progression to management of larger and more complex
  
  

Salary Range: $90,000-$95,000 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 & Training Reimbursement.

Time Off: Vacation, Time Off, Sick Leave & Holidays.

Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.