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