Senior Program Manager at Intuity Medical
Fremont, CA, US

Position Summary:

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.

Position Description 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

Desired Skills:

  • 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

Minimum Education:

  • 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