PURPOSE AND SCOPE:

Leads global product development teams. Responsible for global product design oversight 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.

Establishes, implements, maintains, and directs all objectives, requirements, standards, practices, and procedures of the assigned Fresenius site as the site Leader. Helps establish and manage quality standards, safety standards, personnel systems, financial systems, and other facility administrative systems. Responsible for the overall management and direction of the hardware engineering and facilities at assigned site.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Responsible for the overall management and direction of assigned site. Solid reporting line responsibility for Hardware Engineering and facilities. Dotted reported line responsibility for Engineering, Quality, Human Resources, Finance, and Information Technology.
• Leading an R&D team with the aim of achieving high motivation and self-commitment among the employees.
• Management of various international engineering groups in interaction.
• Ensuring adequate development results, especially with regard to degree of innovation, quality, design, technology, time-to-market and planning accuracy.
• Identification of improvement potentials and continuous development of the area of responsibility to increase performance and efficiency, taking into account the state of the art.
• Independent and autonomous design of teams and infrastructure for the best possible implementation of planned projects and strategies.
• Defines goals, objectives, and long-term strategies for a site with high complexity that is critical to the achievement of global business metrics and requirements.
• Directs and controls the broad activities of the site through the interpretation, application, and implementation of company-wide policies and processes appropriate to the functional area.
• Ensures 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.
• Works with financial team to implement measures and metrics to ensure financial goals are met, including meeting cost standards, monitoring, and maintaining operational efficiencies, the development and meeting of facility budgets.
• Collaborates with Quality Systems to ensure implementation and maintenance of quality standards, including meeting compliance/regulatory requirements, establishing, and achieving quality goals and objectives for the site. Engaged in monitoring and managing regulatory compliance.
• Ensures compliance with all applicable Federal and State government regulations.
• Determines budgets, approves, and controls all costs of Facilities. On a monthly basis, reports to senior management on causes for variances and appropriate corrective actions. Recommends and initiates improved methods and procedures resulting in lower operating costs.
• Promotes and maintains effective relationships with management, governmental agencies, and customers in support of all matters within the scope of responsibility of the role.
• Analyzes, evaluates, and presents information to senior manufacturing leadership concerning factors such as quality standards, people development, economic trends, and the introduction of new methods within assigned facility.
• Recommends alternative methods and procedures for resolving problems/issues that may arise.
• Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures.
• Conducts regular meetings with site line managers management team to establish clear expectations and to provide and receive feedback.
• Reviews technical problems and procedures of assigned departments and recommends solutions to operational problems.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
• Remains knowledgeable and current on SOPs, cGMP, ISO Standards (EN ISO 13485), Canadian Regulations, and other regulatory policies and guidelines.
• 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 teams understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Establishes and maintains effective internal systems and controls to promote compliance with these requirements.
• Provides leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce. Partnering with Human Resources on employee matters.
• Maintains general housekeeping of working area and site.
• Maintains a good attendance record.
• 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.
• Willingness to travel internationally.

SUPERVISION:

• May be responsible for the direct supervision of various levels of R&D and engineering staff.

EDUCATION:

• Bachelor’s degree in engineering sciences in the fields of computer science, electrical engineering, physics, medical technology, or a comparable academic education; Advanced Degree desirable.

EXPERIENCE AND REQUIRED SKILLS:

• At least 10 years practical experience in R&D, desirable in the medical technology industry.
• 10 years’ experience in a senior managerial role.
• Professional experience in managing employees and project teams.
• Good basic knowledge in the engineering disciplines mechanics, electronics, and software
• Knowledge of regulatory requirements for medical devices and risk management is required.
• Leadership experience in relation to employee development, team development, target agreement and coaching – also understanding to lead interdisciplinary teams in a global matrix.
• In-depth knowledge of project management.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Must have strategic agility and make high quality decisions.
• Strong ability to solve problems.
• Very good ability to set priorities and manage conflicts.
• Must be result and action orientation.
• High willingness to learn, fast learning aptitude and distinct perceptiveness.
• Strong ability to build strong teams, motivate employees and courage to lead.
• High competence and ability in building and developing effective teams.
• Must have strong Interpersonal skills along with Professional communication.
• High abstraction and mastery of complexity
• High flexibility, motivation, stress resistance
• Pro-active behavior and organized working method
• Working knowledge of Business Management systems (i.e. SAP); Database software (i.e. MS Access); Human Resource and Payroll systems (i.e., PeopleSoft); Manufacturing software; Order processing systems; Project Management software; Spreadsheet software (i.e., MS Excel), Word Processing software (i.e., MS Word); and Presentation software (i.e., MS PowerPoint).
• Strong Integrity and trust.

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.

“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. Rate: $190, 000 - $316, 000 Location: Concord, Ca"