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