Senior Program Application Manager, Fresenius USA, Inc., a FMCNA company, Waltham, MA
Purpose and Scope:
Responsible for resolving complex engineering and validation process issues related to usability and human factors engineering principles.
Principal Duties and Responsibilities:
- Resolving complex human factors engineering issues and acting as a driver of innovation to ensure that users achieve specified goals with effectiveness, efficiency, and satisfaction in the context of use.
- Leading User Requirements and Usability Engineering Management functions within gPDP.
- Managing, implementing, and documenting the Usability engineering process in alignment with the Human Factors process and in conformance with ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75 and other normative standards.
- Coordinating all measures for compliance required by IEC 62366 requirements for usability-oriented development processes (including analysis, design, and evaluation).
- Managing, monitoring, and evaluating the results of formative and summative evaluations.
- Supporting and consulting the Requirement & Usability-Engineering process for Concept design documents and Usability Engineering Files.
- Supporting and consulting the process of generating product documentation and Terminology.
- Managing knowledge transfer from product-specific transfers, including defining and designing training content and authorization criteria for Training Centers and Clinical Marketing staff.
- Supporting market preparation activities, including consulting Marketing and Sales teams in specific product knowledge for customer communication, and conducting Competitor Analysis in Usability Engineering and user context.
- Leading acquisition and exchange of product and therapy-specific knowledge with physicians and technicians.
- Leading Management Review and Quality Assurance meetings.
- Conducting process and workflow analyses and optimization.
- Defining and maintaining a standardized Usability Engineering information process for products on market.
This position will oversee the work of one (1) direct report in the position of Program Application Manager, responsible for contributing to the resolution of human factors engineering issues.
Education Experience and Required Skills:
This position requires Master’s degree in Biomedical Engineering, Industrial Engineering, Usability/Human Factors Engineering, or a closely related field and 3 years of experience performing usability and human factors engineering for medical devices. Alternatively, will accept a PhD degree in Biomedical Engineering, Industrial Engineering, Usability/Human Factors Engineering, or a closely related field.
Experience, which may have been gained concurrently or in connection with graduate-level coursework, must include experience with:
- Performing statistical analysis in support of usability engineering.
- Ensuring conformance with ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75 and other normative standards.
- Supporting concept design, product documentation, and terminology.
- Market preparation activities including direct observation of initial market release of a product to the field
- Supporting Clinical trials required for product release to the market, followed by any required usability testing for final product submission and clearance.
This position requires 25% domestic and international travel.
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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