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

PURPOSE AND SCOPE:

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 in setting the right priorities and achieves project targets in terms of quality, cost, and time.  Meets departmental and organizational objectives, facilitates issue resolution and performs managerial related duties.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Global Product Development

• Provide strategic leadership of short- and long-term goals using thoughtful techniques in the communication of the company's mission and core values as a means to implement positive change and create organizational structure within the PEC
• 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.

Global Product Oversight

• 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.

 

Global Technical Capability Development

• 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.

 

Staffing and Talent Development

• 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.

Innovation

• 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.

PEC Operations and Other

• 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
• 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.
• Occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.
• The noise level in the environment is usually moderate.
• May be occasionally exposed to bovine blood and serum and human blood products.
• Hepatitis B vaccination is recommended.
• Travel up to 20% as required.
• Remote work schedule permitted as arranged with SVP of PEC

SUPERVISION:

• Responsible for the direct supervision of various levels of Global R&D staff.
•  May directly supervise 5+ Managers/Supervisors/Engineers;
• May include personnel at different global sites within FME.

EDUCATION:

• Masters (M.S.) Degree in a related technological field required.
• Doctoral (Ph.D.) Degree in a related technological field strongly preferred.
• Bachelor's Degree may be considered with additional years of relevant experience.

 

EXPERIENCE AND REQUIRED SKILLS:

• 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. Leads through influencing and convincing others rather than using direct authority. Effective negotiation and conflict resolution skills.
• Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
• Experience successfully collaborating with internal and external stakeholders. Excellent team building skills.
• 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, on time and on budget.
• 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.  Effective in influencing across functions.
• Ability to lead and influence executives and peers to ensure best possible outcomes.
• Sensitive to cultural diversity at all levels
• Strong drive and results oriented.  Ambition to be world class - passion.
• Ability to read, analyze, and interpret most complex scientific and technical journals, financial reports, and legal documents. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and general public.
• Must have ability to communicate and navigate throughout the organization with a high level of English, both spoken and with scientific writing skills; including preparing and presenting updates to executive management.  Other language skills are a great advantage.
• Knowledge of the following: internet software, Project Management software, spreadsheet software, and word processing software.  [MS Office, PowerPoint, Excel; and Project]
• Thorough understanding of corporate and industry practices, processes, standards etc., and their impact on project activities are vital.  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. Audit experience or experience in a regulated industry is beneficial.
• Strong understanding of financials and financial drivers. Deliver accurate financial figures (status reports, cost estimates, etc.) to guide decision-making activities of the Executive Team
• Excellent oral and  written communication skills.
• Must have thorough technical knowledge of design process for single use medical devices.
• Knowledge of medical device guidelines, guidance documents and references.

  

  

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Annual Rate: $00.00 - $00.00

Non-Bonus Eligible Positions: include language below.
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

Bonus Eligible Positions – include language below.
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.

  

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

Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors