We Hire America Jobs

Position Summary:

NxStage is seeking an exceptionally talented and motivated individual to join our growing Program Management Office team in our Lawrence location. As a senior project manager, you will enjoy a high degree of organizational latitude and will have accountability and responsibility for cross functional program/project planning, leadership and success.

The Program Management Office is responsible for the cross-functional management of selected critical programs and projects. This group of program and project management professionals ensures the successful definition, development and delivery of projects, adhering to critical processes, standards, and best practices, in order to provide on time delivery and significant value to our partners and clients.

Working with team members from many different locations across the globe, the PMO is part of an organization that fosters a dynamic, innovative and entrepreneurial environment focused on leveraging cutting-edge technology to develop industry-leading products.

Responsibilities:

• As a program/project leader, you will be the key point of contact for all related activities.

• Leads, manages, coordinates, and reports on the cross functional end to end view of large new product development programs/projects.

• Assembles and drives cross-functional teams, identifies resources needed, and develops detailed plans and schedules to ensure on-time completion of programs from Concept through Commercialization.

• Working with many cross functional workstream leads and projects managers, ensures that program level cross dependencies are identified and program risks mitigated.

• Work with Subject Matter Experts to define the future state process to support labeling compliance.

• Work with the SMEs to define and document the business requirements around the Labeling initiatives.

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

• When necessary, the senior project manager will work within certain project or work streams, within the program, to address and mitigate issues, assist in moving road blocks, and get the proper attention and visibility on matters promptly.

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

• Obtains status from project managers within the program to ensure a complete view of the program is reflected and understood.

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

• Cultivates inter-departmental relationships with all stakeholders.

• Assemble and drive large cross-functional program teams, identify resources required, and develop detailed cross-functional program plans to ensure the on-time completion 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.

• Work collaboratively with your peers and managers within the Global Program Management Office to develop methods for continuously improving productivity and efficiency within the organization.

• Facilitate decision making between program and project team members.

• Escalation involvement around technical and non-technical issues that related to the program.

• Assessing cross program impacts and risks and working with team members to understand mitigation approach.

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

• Understanding of the economic targets of the program if applicable.

Education & Qualifications:

The successful candidate will possess:

• 5-8+ years of project or program management experience in a regulated manufacturing environment.

• 3-5 years 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

• Demonstrated experience managing large cross functional teams of 20 or more people across multiple locations.

• Experience working with 3rd party suppliers and contract manufacturers.

• Experience managing large program budgets and understanding program economic modeling.

• 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, fluids, 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.

• Past experience dealing with Labeling within a Medical Device environment a plus.

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

• 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.