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Director Project Leadership

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Fresenius Kidney Care Eupora

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Location:
United States of America , Concord

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

The Director of 2008 Product manages and sustains the product in the U.S. market and leads a cross-functional development department within the Value Stream Machines, 2008 Product Stream. The function is characterized by strong leadership behavior and a proven business product orientation. The function acts as manager, mentor or idea provider and promotes the development of his organization and its members. It enhances the success of the associated teams through its management skills and technical breadth. The function shares its broad business perspective with others and effectively represents the organization to cross-functional stakeholders, downstream and upstream, customers and external groups. Function is leading upstream stakeholder activities for the US market. • Owns budget for the 2008 cost center and leads 2008 projects (P&L responsibility). • Therapy lead HD portfolio marketed in U.S. • Owning planning, prioritization and allocation funds, sales volumes for 2008Tmarket and/or customer initiative • Leading and developing the development teams with the goal of functional excellence and high motivation. • Promoting a culture of continuous improvement and a lean process landscape. • Definition and further development of methods and infrastructures of the global teams, with the goal of harmonization, increase efficiency. • Management of/ processing of structural projects (i.e. process improvements) within the area of responsibility. • Is knowledgeable and current on SOPs, cGMP, ISO Standards (EN ISO 13485), US Regulations, Canadian Regulations, and other regulatory policies and guidelines. • Serves as transatlantic communication bridge from the Value Stream Team from USA and VSM Headquarters in Schweinfurt, Germany

Job Responsibility:

  • Leads the global product development group (PDG) in the Product Engineering Center (PEC)
  • Responsible for developing and leading product development teams
  • Responsible for global product design oversight for the PEC including harmonizing and sustaining global product designs
  • Conducts research and development towards innovative products and identifying new technology platforms
  • Applies in-depth understanding to lead multicultural cross-functional activities and project activities in a variety of geographic locations
  • Meets departmental and organizational objectives, facilitates issue resolution and performs managerial related duties
  • Provide strategic leadership of short- and long-term goals
  • In collaboration with other senior management, develop, implement, and maintain a global product development strategy
  • Develops detailed engineering and scientific specifications for major engineering projects
  • Prepares and presents to executive management project updates, design concepts, and other information as needed
  • Acts as a subject matter expert and representative of GRD design ownership for PEC products
  • Works closely with GMQS and sustaining center to maintain processes/systems to ensure all the product designs are under appropriate control
  • Oversees and prioritizes all sustaining projects of commercialized products, which may influence product designs
  • Suggests and proposes alternative methods and procedures in solving problems and meeting changing market opportunities
  • Interacts with and provides technical support to other functions within the global PEC, GMQS, marketing, regional regulatory, and sustaining center
  • Develops or revises Standard Operating Procedures (SOPs) and working practices
  • Seeks and interacts with external consultants if needed on project related technical matters
  • Oversee the development of facilities, working tools, and competence for the PEC and ensure processes required for optimal performance of work are available globally
  • Defines the core technical capabilities together with other PEC functional leaders
  • In collaboration with other PEC functional leaders develops the roadmap for the evolution of technical capabilities required in the future
  • Identifies the key technical competencies within PEC
  • Develops programs to promote collaboration and sharing across regions
  • Supports the head of PEC in formulating and establishing strategies, operating process and goals
  • Reviews technical problems and procedures of departments and recommend solutions to problems or changes in procedures
  • Overall responsibility for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations
  • Recruits talent and builds up technical team and ensures employee satisfaction via coaching/feedback, training, professional development, and recognition
  • Collaborate with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization
  • Ensure all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local and national laws, and regulations
  • establishes and maintains effective internal systems and controls to promote compliance
  • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
  • Responsibilities include interviewing, hiring, and training employees
  • planning, assigning, and directing work
  • appraising performance, rewarding and disciplining employees
  • addressing complaints and resolving problems
  • Drives innovation culture and initiatives through PEC innovation program
  • Sponsor proposals for new projects
  • Contributes to the generation of ideas and potential innovations to be used in new products
  • Prepares invention disclosures
  • In collaboration with Global Intellectual Property group, oversees development of patent documentation
  • Reviews patent literature
  • Prepare journal publication submissions, and presentation of abstracts to build external scientific recognition of new product value
  • Coordinate technical support to build brand/product value during post-release lifecycle of new products
  • Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry
  • Participates with other senior managers to establish strategic plans and objectives
  • Develops strategies for direct departments, and contributes to the development of divisional/business unit strategies
  • In collaboration with other senior managers in the PEC, develop annual budget and ensure that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods
  • Prepare capital requests and track spending on capital projects
  • Cultivate a globally harmonized working culture and approach within the business unit
  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
  • Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
  • establishing and maintaining effective internal systems and controls to promote compliance
  • Interprets and provides recommendations for change of company-wide policies and practices
  • Establishes policies appropriate for the function
  • Interacts with all levels within the organization to manage functional area
  • Travel up to 20% as required

Requirements:

  • Masters (M.S.) Degree in a related technological field required
  • Doctoral (Ph.D.) Degree in a related technological field strongly preferred
  • Minimum 10+ years' related experience
  • 5+ years' experience as a Manager
  • or 5+ years' experience in a senior managerial role
  • Strong and experienced manager in both direct and indirect people management
  • Effective negotiation and conflict resolution skills
  • Strong interpersonal skills
  • Experience successfully collaborating with internal and external stakeholders
  • Able to delegate activities and manage resources, as well as to multitask, prioritize, and meet deadlines
  • Ability to conceptualize ideas, motivate and focus individuals and teams, and drive projects through to completion
  • Must have critical and analytical thinking skills, and ability to drive innovation, process improvements, and change
  • Ability to leverage/engage/empower others to accomplish projects
  • Ability to lead and influence executives and peers
  • Sensitive to cultural diversity at all levels
  • Strong drive and results oriented
  • Ability to read, analyze, and interpret most complex scientific and technical journals, financial reports, and legal documents
  • Must have ability to communicate and navigate throughout the organization with a high level of English, both spoken and with scientific writing skills
  • Knowledge of the following: internet software, Project Management software, spreadsheet software, and word processing software
  • Thorough understanding of corporate and industry practices, processes, standards etc.
  • Including an understanding of current ISO 13485 standards as well as familiarity with Good Laboratory Practices (GLP) and FDA Quality System Requirements, medical device guidelines, and Pharma regulations are essential
  • Strong understanding of financials and financial drivers
  • Must have thorough technical knowledge of design process for single use medical devices
  • Knowledge of medical device guidelines, guidance documents and references

Nice to have:

  • Other language skills are a great advantage
  • Audit experience or experience in a regulated industry is beneficial
What we offer:
  • medical insurance
  • dental insurance
  • vision insurance
  • a 401(k) with company match
  • paid time off
  • parental leave
  • potential for performance-based bonuses depending on company and individual performance

Additional Information:

Job Posted:
January 06, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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