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Human Factors Engineer

4 months ago

Waltham, United States Fresenius Medical Care Full time

PURPOSE AND SCOPE

Program Application Manager (PAM) II is an expert within the Global Therapies Program with extensive and in-depth knowledge of markets, clinical application and work flow, Usability Engineering Management and validation processes for products and systems within the product portfolio. PAM II resolves complex issues and acts as a driver of innovation in the dedicated GTP product area to ensure that users achieve specified goals with effectiveness, efficiency, satisfaction, and safe in the context of use. PAM is a team member with multi-functional stakeholders to develop and shares his knowledge with the aim of innovative and attractive products / systems with added value for all stakeholders.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Customer Service

* Responsible for driving the global FMCNA culture though values and customer service standards.
* Accountable for outstanding customer service to all external and internal customers.
* Develops and maintains effective relationships through effective and timely communication.
* Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.

Other Duties and Responsibilities

Performs Usability Engineering Management within the global Product Development Process (gPDP) in general and as member of the Cross Functional Team

* Manage, accomplish and document the complete Usability Engineering Process in alignment with the Human Factor guidance and in conformance with the international and national normative standards (e.g. ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75)
* Coordination and conduct all measures for compliance required by internal and normative standards e.g. IEC/ISO 62366 requirements for usability-oriented development processes (analysis, design, evaluation)
* Manage, monitor, evaluate and document the formative and summative evaluations


* Support and consult the Usability-Engineering & Requirement engineering process in cooperation with:
* PPM, Engineering Manager and Marketing Manager (e.g. Market, customer and user needs analysis, context analysis, process analysis)
* Program Engineering Center, Technical Project Manager


* Support and consult the process of generating product documentation & terminology
* Support and consult the terminology process
* Support and consult the generation of IFU / SM / Service Tools
* Processing, review and partial release of the product specific documentation e.g. IFU, SM, Usability File


* Manage the knowledge transfer by product specific trainings
* Manages and conducts the authorization of Training Centers (TC), Clinical Marketing and Marketing regarding product applications and services
* Definition of product / system specific training content
* Training & authorization of TC Application / TC Service /Marketing


* Support of market preparation activities to enter the markets
* Support and consult Marketing and Sales in specific product knowledge for customer communication
* Competitor Analysis in terms of usability engineering and context of use



Communication internal /external

* Acquisition and exchange of product and therapy specific know-how, exchange experience with users e.g. physicians, engineers, opinion leaders
* Communication and alignment with Program Managers, Project Managers, Product Manager and relevant markets e.g. Marketing, Regional Country Manager
* Visit of specific conferences related to medical device research and development
* Participation and cooperation in national and international committees
* Participant and cooperation of quality assurance meetings and appropriate interface sessions of the different areas, if delegated

Process analysis and optimization within Innovation Management

* Performance and evaluation of process and workflow analysis in cooperation with Provider Business and Clinics to support the innovation management team
* Support and collaborate the innovation management with expert know how and focus on usability engineering and user experience

Application expert support / GRD Face to market

* Processing of global customer inquiries (e. g. from Sales, Marketing, Quality Management, Technical Operations)
* Definition and maintenance of a standardized information process to market
* Collaboration and support QM/QREM in Task Force Teams
* Interaction and support with PCM, PEC`s and Product Center

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.

EDUCATION:

* Minimum BA/BS in Biomedical Engineering, Usability Engineering/Human Factors Engineering, or related field.
* Master's degree preferred in combination with degree in Usability Engineering/Human Factors Engineering

EXPERIENCE AND REQUIRED SKILLS:

* 8 - 12 years' related experience; or a Master's degree with 6 years' experience; or a PhD with 3 years' experience; or equivalent directly related work experience.
* Minimum of 4 years' experience with medical devices preferred in renal replacement therapy / extracorporeal therapies
* Profound knowledge in usability engineering management preferably in the medical device industry related to regulatory and normative standards
* Basic knowledge in Work flow and Process analysis
* Good knowledge of Project Management methodologies tools and best practices
* Strong commitment and flexible organization of working time and environment
* Ability to work independently using a quality and result orientated approach
* Proven organizational and planning skill
* Ability to work independently as well as in a team environment
* Demonstrates initiative; results oriented; strong sense of urgency.
* Strong analytical, planning, organization and time management skills
* Effective decision-making skills and the ability to negotiate and balance decisions and priorities across needs of several functional departments and willingness to make tough decisions.
* Excellent social skills and competencies in cooperation, conflict management and team skills
* Excellent communication and negotiating skills
* Build cross functional relationships
* Broad understanding of diversity and inclusion within the work environment
* Profound analytical skills and exceptional network thinking capabilities

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.