Available Openings 1
Global Research & Development
Our Global Commitment to Deliver
Around 3 million individuals worldwide suffer from renal failure. With innovative products and therapies we define highest standards for the dialysis treatment of patients with chronic kidney failure and extracorporeal therapies for organ support.
Our Global Research & Development (GRD) activities enable us to develop products efficiently and to systematically promote the exchange of knowledge and technology between regions. Our intention to develop innovative products that are not only of the highest quality, but are also affordable so that caregivers and patients can benefit from them.
PURPOSE AND SCOPE:
Utilizes advanced knowledge and expertise to provide IT, web, and mobile related solutions within the Global Research and Development in support of new Fresenius dialysis products and services. Partners with broad stakeholders from Marketing/Product Management, Quality, Regulatory and Compliance teams, and department Program Managers, Systems Analysts, Hardware, Software and Systems Engineers regarding requirements gathering and reviews and the ultimate commercialization of new Connected Health innovation. Analyzes and translates customer requirements and user needs information into technical specifications to align resources to support the companion architectural blueprint that outlines how the delivered solutions achieve the business objectives. Works with these various team members to ensure multiple new and existing technologies work together making a significant contribution towards the success of the product and services suite. Requires both hands on leadership and the ability to guide the collective team to develop solutions leveraging both internally developed and external technology partners. Supports the Fresenius overall product and service vision, core values, and customer service philosophy that may be realized over a number of releases.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Utilizes wide-ranging experience and uses professional concepts in developing resolution to critical issues and broad design matters. Responsible for leading translating of business objectives and requirements into architecture solutions, high level system specifications and lower level functional and interface specifications
- Works with development teams and partners to align execution with delivered specifications
- Member of the Cross Functional Team (CFT) in selected projects.
- Drives designing the system architectures for medical device connectivity and cloud service operation.
- Facilitates safety/hazard requirements at system level (medical device + peripherals + cloud service components + users).
- Establishes a network and close collaboration with national and international partners, external (e.g. authorities, Standards, Certified Bodies), as well as in the company.
- Responsible of resolution of interfaces and integration of different system components.
- Actively works on Market and Customer Needs Document (MCND) with Marketing.
- Ensure proper technical content and feasibility of defined solutions.
- Ensures timely preparation of system architecture to express system components, interfaces, and deployment models.
- Authors technical specifications and socializes with development teams
- Leads preparation of the initial system risk analysis with the quality/risk team
- Works with both internal and external business partners and consultants on the overall user experience design and support the usability and human factors team.
- Provides architecture and system level support as key subject matter expert to help the development team with software build and test processes
- Provides support for Connected Health services, product/vendor evaluations, hardware integration, and production execution and commissioning. Contributes to architectural and design activities with focus on system integration (hardware & software), connectivity, usability, scalability, security, and ongoing supportability of software components.
- Provides technical guidance and expertise to developers and team members on intended system.
- Acts as subject matter technology expert in areas of IT systems, web, and mobile based products (tablet, smartphone, wearables).
- Participates in managing communication, dependencies, and priorities across teams engaged in business analysis, engineering and QA, in different time-zones.
- Ensures system solution meets business requirements for high availability, reliability, and performance of any hosted or patient/healthcare provider facing web applications and services.
- Collaborates with different IT and functional departments including infrastructure, program management, operational procedures and Quality Assurance.
- Provides regular updates to manager and project stakeholders regarding the status of the project.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead). Networks with key contacts outside of area of expertise.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists with various projects as assigned by a direct supervisor.
- 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.
- 25-30% travel.
- Bachelor’s Degree required; Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 8 – 12 years of related experience in product development with a focus on system architecture of medical devices/IT systems; With a Master’s Degree a minimum of 6 years of experience required.
- Experience developing Java based web applications in a Linux/Unix environment. (JDK 1.5/1.6).
- Experience developing and maintaining connected solutions (examples: telemedicine, telehealth, medication adherence, personal emergency response services, home alarm systems)
- Strong understanding of GDPR, HIPAA, FDA Cybersecurity Guidance, IEC 62304 medical device software life cycle and FDA 510k and EU MDR process requirements.
- Strong focus on customer benefit and satisfaction.
- Project management and team leadership experience; ability to work with team members both onsite and offshore. Strong mentoring abilities. Strong organization and prioritization skills. Exposure to Agile development processes.
- Excellent technical aptitude with the ability to think independently.
- Excellent communication (verbal and written) and interpersonal skills. Experience in analyzing business requirements and producing detailed technical specs. Strong analytical and problem solving skills. Proven collaborative skills.
- Attention to detail. Must be process oriented.
- Ability to identify alternative solutions/approaches to risks and issues.
- Extensive knowledge of multiple hardware/software environments; ability to work in complex heterogeneous systems environments.
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.
You do not have any recently viewed jobs
You do not have any saved jobs