PD Project Management Specialist

MiniMed•Los Angeles, CA

7d•$87,000 - $165,000•Onsite

About The Position

Manages the operational documentation aspects of ongoing projects and serves as a liaison between project management and planning, project team, and line management and quality standards. Manages the development and design of R&D Project documentation and implementation process of a company’s products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes. Responsible for Design Document/Records Maintenance/updates according Quality Regulation Standards. Responsible for execution and maintenance of Design Control quality records, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in the Change Management system, interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems. Monitors the project from initiation through delivery. Develops mechanisms for monitoring project/activities progress and for intervention and problem solving with project managers, line managers, and clients. Manages the development and implementation process of a company’s products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes. An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills. Manage the design records changes monitoring product implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products. Monitors change and project timeliness to ensure design records delivery on time according project plans. Support the PD Program Management Organization with any design change as required.

Requirements

Bachelor’s degree with 2+ years’ experience in a regulated industry, or Advanced degree with 0 years of experience.

Nice To Haves

Project management
Risk management and data-driven
Quality management systems knowledge
Regulatory compliance knowledge
ISO Regulation and Medical Devices Regulations

Responsibilities

Manages the operational documentation aspects of ongoing projects and serves as a liaison between project management and planning, project team, and line management and quality standards.
Manages the development and design of R&D Project documentation and implementation process of a company’s products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
Responsible for Design Document/Records Maintenance/updates according Quality Regulation Standards.
Responsible for execution and maintenance of Design Control quality records, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in the Change Management system, interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
Monitors the project from initiation through delivery.
Develops mechanisms for monitoring project/activities progress and for intervention and problem solving with project managers, line managers, and clients.
Manages the development and implementation process of a company’s products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
May act as a mentor to colleagues or may direct the work of other lower-level professionals.
Manage the design records changes monitoring product implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products.
Monitors change and project timeliness to ensure design records delivery on time according project plans.
Support the PD Program Management Organization with any design change as required.