Senior Program Manager- R&D - Medical Device

Overview

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.

We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary:

Plan and manage a large multi-functional product development project and/or several small multifunctional product development projects simultaneously. The projects may include large multi-functional projects or a combination of hardware, software, and sustaining projects. The position requires strong, enthusiastic leadership skills in a highly technical medical instrument product development environment. Provide direct supervision to program managers and project managers who are responsible for the projects or major subprojects within the program.

Participate in business strategic planning representing current projects and implementing the business strategy. The position requires regular interaction with all functions and levels of the organization from R&D scientists and engineers, marketing/sales, quality/regulatory, and operations, through executive management. Directs the program team and project team(s) in a manner to achieve the business results expected. Forecast program results when requested. Seeks guidance on unusual and complex problems whose solution exceeds the approved project or program boundaries.

Authority of position is that required to carry out assigned duties, except where expressly reserved by the senior management personnel or Werfen Corporate/Division Policy.

Key Accountabilities

Essential Functions:

• Program Leadership
  :
  This item includes providing technical and team leadership to one or more large project team(s) or program team(s). This may include directly leading one of the projects. Leadership entails planning, scheduling, assignment of work, and technical support within the program area. Drive the successful attainment of program goals.
• Project Planning and Scheduling
  :
  Responsible for project or program planning and scheduling, clarifying and defining the scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates. Generates integrated project plans that meet business objectives and are in compliance with the design control process, while maximizing resource efficiency.
• Project Execution and Control
  :
  Responsible for conducting regular project or program team status meetings and reviews. Ensures deliverables are completed and documented. Identifies the need for and implements changes to the program and project plans that are within approved program and project boundaries.
  
  Plan and conduct major program and supporting project and milestone reviews.
• Agile Project Management
  :
  Participates in the decision-making process regarding when to employ the Agile methodology. Ensure adequate resources are applied to Agile projects.
• Problem Solving Leadership
  :
  Responsible for coordination of program and project resources to identify the root cause(s) of program and project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion.
• Risk Management Leadership
  :
  Responsible for ensuring program and project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are included within the program and project plan. Regularly assess and report the status of overall program risk remaining on a program. Identify risk trends and patterns across the program and develop risk mitigation strategies for systemic risks.
• Design Control
  :
  Creates and maintains file to current phase ensuring accuracy. Ensure compliance with Design Control practices.
• Communication
  :
  Responsible for program communication for both within the project team(s) and between the team(s) and executive management.
• Vendor Management
  :
  Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project.
• Cross Department…