Director Project Leadership Job at Fresenius Kidney Care Eupora (Concord)

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

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