Fresenius Medical Care · 3 days ago
Director Project Leadership
Concord, CA
Full-time
Hybrid
Director/Executive
10+ years expFresenius Medical Care is a leading provider of products and services for individuals undergoing dialysis. The Director of Project Leadership will manage and sustain the 2008 Product in the U.S. market, leading a cross-functional development department and ensuring effective communication and collaboration across various teams and stakeholders.
BiotechnologyHealth CareMedical Device
Responsibilities
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
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
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
Other duties as assigned
Additional responsibilities may include focus on one or more departments or locations
Qualification
Required
Masters (M.S.) Degree in a related technological field required
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
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
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
Preferred
Doctoral (Ph.D.) Degree in a related technological field strongly preferred
Bachelor's Degree may be considered with additional years of relevant experience
Benefits
Medical, dental, and vision insurance
A 401(k) with company match
Paid time off
Parental leave
Company
Fresenius Medical Care
Fresenius Medical Care is a healthcare company that provides dialysis treatment for those with chronic kidney diseases.
10001+ employees
H1B Sponsorship
Fresenius Medical Care has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (5)
2023 (14)
2022 (18)
2021 (10)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
$758.43M2025-11-17Post Ipo Debt· $579.5M
2025-07-21Post Ipo Equity· $4.86M
2020-02-25Post Ipo Equity· $6.07M
Leadership Team
Helen Giza
Chief Executive Officer
Olaf Schermeier
Member of the Management Board - CEO Global R&D
Recent News
2025-11-19
2025-11-11
Company data provided by crunchbase