The Senior Program Manager has a Bachelor of Science degree in an engineering discipline and 8+ years of experience in consumer product development, diagnostics and/or medical equipment and device development or its equivalent. Reporting to Head of Program Management, this individual manages and executes program direction in accordance with the client and development team goals. In addition, this individual has experience with leading and directing business development initiatives regarding specific clients. The Sr. Program Manager will be responsible for managing major/complex programs and leading various disciplines in executing the required deliverables. It is expected that these programs require discipline leaders and multiple team interfaces. The ability to interact with clients from project initiation through the entire development process is a must. 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
• Client /Team Management responsibility including overall client satisfaction, profitability, etc. and that client program is maintained. Awareness of client satisfaction level and client needs for differing levels of service.
o Maintain program oversight over all disciplines. Ensure individual discipline leaders are aware of client overall objectives and their responsibilities to the specific programs. Escalate any issues as appropriate to higher level management.
• Sound program management skills, including task scheduling, budget tracking,
o Develop and Maintain schedule, including resource needs to accomplish tasks.
o Ensure program profitability, and that proposal deliverables are completed on time and within budget
o Ensure program is compliant with the Ximedica product development process, including Ximedica’s SOP’s guidelines.
o Ensure that any out of scope work is approved by either the client and/or internally.
o Advocate and maintain appropriate resource loadings needed to maintain project deliverables, including budget and schedule.
o 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
o 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.
o Maintain day-to-day relationships with client companies o Submit weekly project status dashboards to internal management and/or client.
o 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
o Ensure that each team member is aware in writing the time (work effort and duration) allotted for activities.
o 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
• Experience with Agile product development processes and tools
• 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 processes, 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 processes.