- Date Job Description Completed: April 20, 2021
- Reports to: Vice President of Operations
- Supervises: Program Managers
- Exempt/Nonexempt: Exempt
Essential Duties and Responsibilities
- Department Specific Duties and Responsibilities
- Provides strategic direction for the SynCardia TAH-t and Driver System development and engineering projects.
- Advises senior management on the status and resource planning for the project portfolio. Works with senior management on the prioritization of various projects.
- Provides leadership, oversight, direction and coaching to Program Managers to ensure projects are conducted in compliance with Design Control regulations and procedures, while still meeting schedule and cost objectives.
- Monitors the status of all active projects and allocates resources appropriately.
- Position Specific Duties and Responsibilities
- Responsible for the project planning and execution of planned activities relating to new product development and existing product design changes.
- Responsible for gathering and prioritizing product and user requirements, defining the product vision, coordinating development and authorship of design output documentation, and coordinating verification and validation testing activities and risk management activities while working closely with engineering, quality, regulatory and clinical support to ensure revenue and customer satisfaction goals are met.
- Lead a team that is charged with the TAH-t and Driver product line development and evolution.
- Actively participate in transfer of new products/design changes into manufacturing while ensuring that quality documentation requirements are achieved. ex. Ensure proper phase reviews are conducted to meet design control requirements to support QMS.
Responsibility and Authority Affecting Quality
- Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
- Identify and record potential problems relating to the product, process and Quality System.
- Initiate, recommend or provide solutions through designated channels.
- Verify the implementation of solutions.
- Skills and abilities (required for the job)
- Excellent communication and organizational skills.
- Strong computer skills including Microsoft Word, Excel, Outlook and Project.
- Strong writing skills.
- Ability to handle multiple tasks simultaneously.
- A team player.
- Education, experience and training (required for the job)
- Bachelor’s Degree in Business, Engineering or Biological Science discipline or equivalent required.
- Seven or more years of experience as a Program Manager in a regulated industry with a thorough understanding of design control procedures for new and existing product design from conception through design transfer.
- Proven track record of leading teams and managing technical personnel in product design and development through design transfer to manufacturing.
- Ability to plan and execute activities required to assure product and process quality in accordance with quality policy principles, procedures and controls.
- Working environment
- Work Station Area: Office.
- Special Factors in the Work Area: None
- The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
- The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
- The position requires the ability to communicate in person, telephonically and via email.
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