NxStage Medical, a Fresenius Company is on a mission totransform renal care. To do that, we continually seek the best-of-the-best toexpand and improve our team of dedicated, innovative professionals. If youshare our mission and are committed to improving the lives of renal patients,then we invite you to explore our career opportunities.
NxStage a Fresenius Medical company is seeking an exceptionally talented and motivated individual to join ourgrowing Program ManagementOffice team in our Lawrence location. As a program manager, you will enjoy ahigh degree of
organizationallatitude and will have accountability and responsibility for cross functionalprogram planning, leadershipand success.
TheProgram Management Office is responsible for the cross-functional management ofselected critical programsand projects. This group of program and project management professionalsensures 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 andclients.
Workingwith team members from many different locations across the globe, the PMO ispart of an organizationthat fosters a dynamic, innovative and entrepreneurial environment focused onleveraging
cutting-edgetechnology to develop industry-leading products.
Asa program leader, you will be the key point of contact for all program relatedactivities
Leads,manages, coordinates, and reports on the cross functional end to end view oflarge new productdevelopment programs
Assemblesand drives cross-functional program teams, identifies resources needed, anddevelops detailedprogram plans and schedules to ensure on-time completion of programs fromConcept throughCommercialization
Workingwith many cross functional work stream leads and projects managers, ensuresthat programlevel cross dependencies are identified and program risks mitigated
Workwith Subject Matter Experts to define the future state process to supportlabeling compliance
Workwith the SMEs to define and document the business requirements around theLabeling Initiative
Communicatesfrequently with team members and senior business stakeholders regarding program statusand identifies and resolves program problems, issues and risks
Whennecessary, the program manager will work within certain projects or workstreams, withinthe program, to address and mitigate issues, assist in moving road blocks, andget theproper attention and visibility on matters promptly
Initiatesaction to identify and resolve program and project problems/issues and reportson mitigatingsteps and actions taken to ensure timely deliverables, program success andquality
Providesweekly status reports highlighting accomplishments, plans and issues to programteam membersand senior management
Obtainsstatus from project managers within the program to ensure a complete view ofthe programis reflected and understood
Developsand promotes best practice process and/or methodology improvements andefficiencies acrossthe organization.
Cultivatesinter-departmental relationships with all stakeholders
Assembleand drive large cross-functional program teams, identify resources required,and develop detailedcross-functional program plans to ensure the on-time completion and launch ofprograms, whichnot only focus on delivering the technical components of the program but alsothe business readinessactivities required to prepare our internal business groups and externalcustomers for the programdeliverables
Workcollaboratively with your peers and managers within the Global ProgramManagement Office todevelop methods for continuously improving productivity and efficiency withinthe organization
Facilitatedecision making between program and project team members
Escalationinvolvement around technical and non-technical issues that related to theprogram
Assessingcross program impacts and risks and working with team members to understand
Managementand understanding of the Economic Model of the program and all of the costing / inputsthat make up the model if applicable.
Understandingof the economic targets of the program if applicable.
Education & Qualifications:
The successful candidate will possess:
5-10+ years of program management experience in a regulated manufacturing environment.
5-7 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
Experience working with 3 rd 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