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Heart and Lung Program Manager


Waltham, Massachusetts

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Address: Headquarters Job ID R0116114

Seeking an exceptionally talented and motivated individual to join the Heart & Lung value stream within the Fresenius Critical Care & Ventures Organization in our Lawrence location. As a program manager, you will enjoy a high degree of organizational latitude and will have accountability and responsibility for cross functional program planning, leadership and success. Responsible for the cross-functional management of selected critical product development & registration programs and projects for the US market. Ensures the successful definition, development and delivery of projects, adhering to critical processes, standards, and best practices, in order to provide on time delivery.

Responsible for providing comprehensive planning, execution and management of projects and programs to support business goals and strategy, as well as creating and managing long term goals and participating in the continuous improvement of project management best practices, processes and tools.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • As a program leader, you will be the key point of contact for all program related activities regarding Heart & Lung product regulatory registration in the US.

  • Initiate programs by clearly defining program objective, scope, stakeholders and benefits. Conduct detailed planning by creating program structure and plan and securing cross functional support and buy-in.

  • Assemble and drive cross-functional program teams, identify resources required, and develop detailed cross-functional program plans to ensure the on-time completion, regulatory submission and launch of programs, which not only focus on delivering the technical components of the program but also the business readiness activities required to prepare our internal business groups and external customers for the program deliverables.

  • Develops and owns project plans and ensuring key milestones are identified and communicated to key stakeholders. Works with various business leaders and representatives to ensure delivery of key project milestones on time and within budget, resource and policy.

  • Communicates frequently with team members and senior business stakeholders regarding program status and identifies and resolves program problems, issues and risks.

  • Initiates action to identify and resolve program and project problems/issues and reports on mitigating steps and actions taken to ensure timely deliverables, program success and quality.

  • Provides status reports highlighting accomplishments, plans and issues to program team members and senior management.

  • Develops and promotes best practice process and/or methodology improvements and efficiencies across the organization.

  • Work collaboratively with your peers within the Heart & Lung value stream and cultivates inter-departmental relationships with all stakeholders.

  • Meets with stakeholders to make communication easy and transparent regarding project issues and decisions.

    · Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

  • Management and understanding of the Economic Model of the program and all of the costing / inputs that make up the model.

    o Understanding of the economic targets of the program

  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

  • Assist with various projects as assigned by a direct supervisor.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

10% – 20% travel.

EXPERIENCE AND REQUIRED SKILLS:   

  • A bachelor's degree and 8-12+ years (or a master's degree and 6+ years of experience) of program or project management experience in a regulated manufacturing environment working within new product development in the medical device space.

  • Demonstrated understanding of NPI, Design Controls, GMP etc.

  • Demonstrated ability to work across multiple job levels to achieve results.

  • Proven track record in delivery of small to medium-scale projects and programs

  • Proven ability to manage multiple projects simultaneously in a deadline driven process.

  • Consistent success in driving teams to meet aggressive deadlines.

  • Experience in New Product Introduction lifecycles that include physical hardware, disposables, as well as embedded or application software.

  • Demonstrated use of sound and proven program / project management practices and tools, including excellent MS Office skills.

  • Demonstrated ability to identify and implement process improvements to deliver programs / projects more efficiently.

  • Proven experience managing expectations and managing cross-functional teams.

  • Excellent interpersonal, written and oral communication skills with all levels of the organization.

  • Outstanding time management and organization skills.

  • Confident team leader and consensus builder with strong motivational skills.

  • Adept in problem solving and resolving conflict.

  • Able to manage internal customer relationships and expectations, through negotiation and partnering.

  • Able to cultivate strong inter- and intra-departmental relationships that promote a positive, execution-focused work environment.

  • Ability to understand both technical and business vision and communicate it to both technical and non-technical partners.

  • Experience in an ISO environment and an FDA regulated environment.

  • Knowledge of agile and lean sigma principles is a plus.

  • PMP certification is a plus.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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