Fresenius Medical Care Job - 33434956 | CareerArc
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Company: Fresenius Medical Care
Location: Waltham, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job ID 20000EAC

Available Openings 1

PURPOSE AND SCOPE:

Provide authoritative level support to Clinical and Technical Services staff on R.O. water systems, dialysis machines and associated equipment. Providing in-depth technical support, technical documentation and training guidance for enhancing FKC facility technical operations company wide. Assists in defining medical equipment standards and applying standards to clinical and/or technical policies and procedures. Supports FMCNA's mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FKC policy requirements.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • A seasoned, experienced professional with a full understanding of their area of specialization; resolves a wide range of issues in creative ways. (This job is the fully qualified, career-oriented, journey-level position.)
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
  • Normally receives little instruction on day-to-day work, general instructions on new assignments.
  • Acts as a subject matter expert on equipment used in end stage renal replacement therapy.
  • May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
  • May escalate issues to supervisor/manager for resolution, as deemed necessary.
  • Mentor other staff as applicable.
  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
  • Provide direction to RECS department for the upgrade or modification of water and concentrate system space designs and needs to assure compliance with device manufacturer requirements, AAMI Standards, pertinent state regulations, or general policy changes in day to day operating procedures of FKC clinics and facilities. Review all design changes proposed by RECS department that impact medical systems and make recommendations as appropriate.
  • Evaluate impact of all water treatment and concentrate delivery system design changes proposed by RECS department. Ensure that proposed changes follow AAMI and ESRD requirements. Evaluate the impact of proposed changes on clinics operating policy and procedures.
  • Provide technical support to FKC facilities by way of direct contact with the clinic or through the ATOM/ ROTM. Provide direction on the procedure or action necessary to resolve technical and bacterial problems associated with the operation of medical, water treatment and concentrate delivery system equipment. Responsibility in this area includes directing the clinic to terminate treatment of patients in those instances where patient safety is at risk.
  • Investigate near misses and causes of equipment failure as they relate to medical device reporting. Recommend corrective action where necessary.
  • Support, and where necessary, direct Technical Services staff activities by telephone and/or site visits. Assign and supervise special projects and duties as requested by Supervisor.
  • Update or write new sections to clinical and technical manuals in accordance with AAMI defined requirements and Company policy. Define or change, where necessary, Company policy on the operation and maintenance of equipment, water quality and dialysate testing procedures. Coordinate changes in policy and procedure with Clinical Services Department as may be necessary.
  • Provide interpretation of AAMI Standards, Clinical and Technical Manuals to various FKC Staff and departments.
  • Assist Regulatory Department in preparing the dialysis clinics written response to technical issues cited by local, state or ESRD surveyors.
  • Assist 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.
  • Physical demand includes those typically encountered working in an office environment.
  • 1 to 5% travel will be required depending on projects and goals.

EDUCATION:

  • Bachelor's degree in a scientific discipline or
  • Associates degree, preferably in a science, with 4 or more years hemodialysis experience may be substituted for a bachelor's degree or
  • 5 Years' experience in a Technical Services Management (ATOM/ RTOM/ FVP) position or
  • 10 or more years working in the technical area of hemodialysis or related science.

EXPERIENCE AND REQUIRED SKILLS:

  • Ability to lead cohesive and productive team projects.
  • Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
  • In-depth practical and theoretical knowledge of medical systems used in providing renal replacement therapy.
  • A commitment to patient safety and patient risk reduction.
  • Strong computer skills and In-depth knowledge of Microsoft Office.
  • Effective and efficient communication skill in both writing and verbal form.
  • Additional skills as may be required for assigned area of responsibility.

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.


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