Program Manager

The Program Manager has a Bachelor of Science Degree and a minimum of 5 years of experience in consumer product development 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 VPPM & VPSO 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 Submit signed proposal and/or PO with program budget breakdown to accounting and business development by accurately completing the project setup sheet at the beginning of each phase
  • 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
  • Ensure that the appropriate filing structure in the WIP/ Smarteam, CTS, etc. is setup
  • 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 senior 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 brainstorming activities
  • Understanding of Industrial Design & 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 research activities and process

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