Vice President, Program System Architect, Fresenius Medical…

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Company: FRESENIUS
Location: Waltham, MA 02451

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Job ID 19000OYX

Available Openings 1


Purpose and Scope:

Responsible for managing the delivery of an information technology connected health system supporting the delivery of in-home hemodialysis treatment.


Principal Duties and Responsibilities:

  • Defining system architecture including medical devices, disposables, and interfaces at the point of care
  • Determining and evaluating machine/consumables/user safety requirements at the systems level
  • Coordinating and leading cross-functional ad hoc teams of system architects and engineers to support the Home Hemodialysis project
  • Evaluating and integrating third-party technology/devices, including: technology screening and scouting; coordinating completion and delivery of third-party services; benchmarking third-party systems; and anaging the integration of concepts, products or organizations.

  • Ensuring system compliance with applicable standards and for quality and safety in all clinical applications, and explaining and defending product concepts to regulatory bodies and customers.

In performing these duties, this position will oversee one direct report: Principal Program System Arch.

Education Experience and Required Skills:

Position requires a Bachelor’s degree (or equivalent foreign degree) in Systems Engineering, Medical Engineering, Engineering Management, or a closely related field and 5 years of experience in the medical product research and development industry. Alternatively, will accept a Master’s degree (or equivalent foreign degree) in Systems Engineering, Medical Engineering, Engineering Management, or a closely related field and 2 years of experience in the medical product research and development industry. Position also requires 2 years of experience (which can have been gained concurrently with the primary experience requirement above) in:

  • Project coordination and milestone planning for medical device research and development
  • Management of content and budget for hardware and software projects
  • Participation in development and revision of product development processes
  • Development of implementation procedures for medical device programs, including:
    • Requirement definition;
    • Risk assessment;
    • Software programming;
    • Product component design specifications; and

    • Device validation.

This position requires domestic and international travel approximately 50-60% of the time.