Project Manager I (Medical Product design & Development)

Abbott Laboratories • Des Plaines, IL

6d • Onsite

About The Position

Responsible for all activities associated with the transfer of one or more new products from R D into Operations, and completion of commercialization activities to achieve the launch of new products. Manages the transfer of moderately complex project or several smaller low complexity projects. Executes project activities in compliance with other functional requirements. Contributes and ensures alignment of assigned tasks to overall project timing. Provides leadership and subject matter expertise to product development team to ensure product design is manufacturable. Creates and gains approval of device master record documents required to manufacture and test the product, including packaging, labeling, and new raw materials. Acts as the key liaison between R D and Operations areas. Communicates and works with Planning to schedule verification and validation lots and initial lots to stock. Follows change control process to assess and implement changes to DMR documents during product development. Creates and approves Design History File deliverables associated with product transfer. Completes transfer activities required for product commercialization. Facilitates discussions and manages the commercialization of TPM manufactured materials required for the product. Works with R D and Operations to develop and implement a manufacturing validation strategy and address equipment, process, and test method validations required for product transfer. Writes and oversees execution of validation master plan. Identifies current issues and potential roadblocks and works with supervisor to develop strategies to proactively resolve issues. Learn and adjust based on prior results. Works with members of cross-functional project team to gather input, coordinate activities, and complete product transfer activities. Solicit the cooperation of cross-functional team members in a tactful and persuasive manner

Requirements

• Bachelor's degree in a discipline appropriate to the project.
• Minimum of 2 years relevant experience.
• Basic knowledge of regulations and standards affecting IVD products

Responsibilities

• Responsible for all activities associated with the transfer of one or more new products from R D into Operations, and completion of commercialization activities to achieve the launch of new products.
• Manages the transfer of moderately complex project or several smaller low complexity projects.
• Executes project activities in compliance with other functional requirements.
• Contributes and ensures alignment of assigned tasks to overall project timing.
• Provides leadership and subject matter expertise to product development team to ensure product design is manufacturable.
• Creates and gains approval of device master record documents required to manufacture and test the product, including packaging, labeling, and new raw materials.
• Acts as the key liaison between R D and Operations areas.
• Communicates and works with Planning to schedule verification and validation lots and initial lots to stock.
• Follows change control process to assess and implement changes to DMR documents during product development.
• Creates and approves Design History File deliverables associated with product transfer.
• Completes transfer activities required for product commercialization.
• Facilitates discussions and manages the commercialization of TPM manufactured materials required for the product.
• Works with R D and Operations to develop and implement a manufacturing validation strategy and address equipment, process, and test method validations required for product transfer.
• Writes and oversees execution of validation master plan.
• Identifies current issues and potential roadblocks and works with supervisor to develop strategies to proactively resolve issues.
• Learn and adjust based on prior results.
• Works with members of cross-functional project team to gather input, coordinate activities, and complete product transfer activities.
• Solicit the cooperation of cross-functional team members in a tactful and persuasive manner

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees