Program Manager

The Program Manager has a Bachelor of Science Degree and a minimum of 5 years of experience in consumer product development, diagnostics, and/or medical equipment and device development or its equivalent experience.

Nature of Role:

Reporting to the Director of Program Management, this individual manages and executes program direction in accordance with the client and development team goals. The following key attributes are required:

  • Flexibility to perform and manage a wide range of activities and willingness to “wear many hats”
  • Outstanding people skills; friendly, confident, competent, great communicator, honest, and sincere
  • Must be a dynamic personality and willing to work within a collaborative team environment
  • Energetic, proactive self-starter who enjoys challenges and variety

Responsibilities:

General:

  • Sound program management skills, including task scheduling, budget tracking
  • Develop and Maintain schedule, ensure schedule has been reviewed by internal supervisor. Schedule will include resource needs to accomplish tasks. Schedule and resource needs to be submitted to management at the beginning of the phase and updated on a monthly basis
  • Ensure proposal deliverables are completed on time and within budget
  • Ensure program is compliant with the Ximedica product development process, including Ximedica’s SOP’s guidelines
  • Ensure invoicing is done within the 1st 5 business days of the following month. Ensure that deposit invoices are submitted prior to start of program.
  • Ensure that any out of scope work is approved by either the client and/or internally. Ensure that additional project codes are utilized to track changes. Ensure that each PO has a separate job code
  • Advocate and maintain appropriate resource loadings needed to maintain project deliverables, including budget and schedule
  • Ensure team members are accurately entering their hours into the accounting system on a weekly basis
  • Ensure program profitability
  • Conduct post-mortem with team members and appropriate senior management on each phase during the program
  • Ability to organize and communicate high-level presentations to clients, clinicians, and participating teams, as necessary
  • Develop with team, appropriate presentations of activities during each phase of program. Ensure that each presentation is reviewed internally by management prior to submitting to client/other
  • Maintain day-to-day relationships with client companies
  • Submit weekly project status dashboards to internal management and/or client
  • Ensure meeting agendas are submitted prior to and utilized during meetings
  • Demonstrated ability to direct and manage resources, make decisions, solve problem, exercise good judgment & flexibility and maintain budgets and schedule
  • Ensure that each team member is aware in writing the time (work effort and duration) allotted for activities
  • Coordinate all aspects of program activities, between the client and Ximedica industrial design, engineering, quality, regulatory, testing, documentation, etc.
  • Ability to communicate with vendors and to proactively monitor internal resources to ensure all products are developed within cost targets and delivered on schedule
  • Ensure Ximedica is meeting the needs of the client and that the device will be successful in the marketplace

Medical Specific:

  • Familiarity in the design of complex medical capital equipment as well as disposable devices
  • Familiarity with appropriate FDA, QSR, and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge
  • Manage the design and development of complex electro-mechanical medical devices and equipment

Other experience:

  • Experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, sheet metal fabrication, etc.
  • Experience in leading concept generation activities
  • Understanding of Human Centered Industrial Design & Usability research activities and their interface with engineering
  • Understanding of Mechanical engineering development process utilizing 3D CAD or related engineering software techniques
  • Understanding of electronics and software development
  • Understanding of Voice of the Customer and User Needs research activities and process

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