Principal Program System Architect (Diagnostics) - Fresenius Medical Care (Billerica)

Compensation

: $108,680.00 - $159,340.00 /year *

Employment Type

: Full-Time

Industry

: Information Technology



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Global Research & Development

Our Global Commitment to Deliver

Around 3 millionindividuals worldwide suffer from renal failure. With innovative products andtherapies we define highest standards for the dialysis treatment of patientswith chronic kidney failure and extracorporeal therapies for organ support.

Our Global Research& Development (GRD) activities enable us to develop products efficientlyand to systematically promote the exchange of knowledge and technology betweenregions. Our intention to develop innovative products that are not only of thehighest quality, but are also affordable so that caregivers and patients canbenefit from them.

Click to Learn more about the Global Research andDevelopment Organization!

PURPOSE AND SCOPE:

Utilizes advanced knowledge and expertise to providediagnosis 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 diagnostic tools for Kidney Disease related parameters.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 diagnostic tools to collect kidneydisease related parameters at the patient home.
  • 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 matterexpert to help the development team
  • Contributes to architectural and design activities with focus on systemintegration (hardware & software), connectivity, usability, scalability,security, and ongoing supportability of software components.

  • Provides technical guidance and expertise to developers and team memberson intended system.

  • Acts as subject matter technology expert in areas of diagnostic tools

  • 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 functional departments includinginfrastructure, program management, operational procedures and QualityAssurance.
  • 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.


    Qualifications

    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.
  • EDUCATION:

  • Bachelors Degree required; Advanced Degree preferred.
  • EXPERIENCE AND REQUIRED SKILLS:

  • Minimum 8 12 years ofrelated experience in product development with a focus on system architectureof medical diagnostic tools; With a Masters Degree a minimum of6 years of experience required.
  • Experiencedeveloping and maintaining at home diagnostic tools

  • Strong understanding of medical device industry and regulation.

  • Strongfocus on customer benefit and satisfaction

  • Projectmanagement and team leadership experience; ability to work with team membersboth onsite and offshore. Strong mentoring abilities. Strong organization andprioritization skills. Exposure to Agile development processes.

  • Excellenttechnical aptitude with the ability to think independently.

  • Excellentcommunication (verbal and written) and interpersonal skills. Experience inanalyzing business requirements and producing detailed technical specs. Stronganalytical and problem solving skills. Proven collaborative skills.

  • Attentionto detail. Must be process oriented.

  • Abilityto identify alternative solutions/approaches to risks and issues.

  • Extensiveknowledge of multiple hardware/software environments; ability to work incomplex 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.


    Associated topics: bacteria, dietary, disease, drug development, histotechnologist, metabolism, microbiological, patient, physiologist, transfection * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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