Project Manager I (Medical Product design & Development)
- 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
- 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
- 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)
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