Senior Program Manager
The Program Manager will be responsible for achieving the successful implementation of projects and managing activities required to define, design, develop and deliver Intuity products.
Duties and Responsibilities:
- Provides direction and leadership to cross-functional program development team including members with expertise from all areas involved in product commercialization
- Responsible for the management of the product development cycle
- Manage the design control process and ensure compliance with product development projects
- Lead role in the organization, documentation, and execution of Design Phase Reviews
- Manage and maintain the Product Requirements Trace Matrix and associated validation requirements.
- Manage and maintain product risk management files and activities
- Manage and maintain the Device Master Record & Design History File
- Ensure appropriate application of statistical tools in meeting specifications and regulatory requirements
- The Program Manager will be responsible for tracking team commitments and ensuring updates are communicated in a timely manner.
- Support Manufacturing Scale-Up and Design Transfer
- Support the Calibration and Preventive Maintenance Program Review by reviewing and approving Calibration and Preventive Maintenance Forms.
- Collaborate with Purchasing and Engineering departments in the selection, qualification, and maintenance of suppliers
- Identify and assist in managing critical materials and supply chain (ie finalize packaging)
- Identify long lead time items, high-risk items, supplier validations and participate in critical supplier audits
- Assist manufacturing with the development and support of product launch schedule
- Working knowledge of regulatory requirements such as QSR, ISO13484, CMDCAS, and IVDD
- Ability to lead and coach diverse team members in achieving project team effectiveness
- Strong collaboration, team building, and development skills
- Demonstrated leadership, critical thinking, and adaptability with cross-functional teams and situations
- Excellent communication, planning and organizing, problem-solving skills, delegation, and facilitation at all organizational levels
- Effective and creative analytical and problem-solving skills
- Strong written, verbal and interpersonal skills
- Strong statistical application experience a plus
- Prior experience working in emerging, start-up companies desired
- The preferred candidate will have a minimum of a bachelor in sciences, engineering or related field with a minimum of 8 years experience in the medical device industry