Head of Global Human Factors Engineering (m/f/d)

Posted:
7/19/2024, 2:38:29 AM

Location(s):
Bad Homburg vor der Höhe, Hesse, Germany ⋅ Hesse, Germany

Experience Level(s):
Senior

Field(s):
Product

In your role as Head of Global Human Factors Engineering (m/f/d) you will be responsible for the Program Application Management and Human Factors Engineering across the In-Center Vertical. From User Research and User Requirements to Validation with various user groups and post market surveillance, your team is responsible for all usability related processes and inputs.

Being the eyes and ears into the real-world application of our existing in-Center products, you lead the transformation into a customer centric product development environment in collaboration with stakeholders and peers like product management, engineering, service, quality & regulatory and care delivery.

Your tasks

Usability Engineering Management within the Product Development Process

  • Manage, accomplish, and document the usability engineering and human factors processes in conformance with global standards and regulations (e.g., ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75)
  • Continuously improve the processes to define market and customer needs, context and task analyses and user feedback
  • Foster close collaboration between human factors experts and engineering teams throughout the product development process
  • Support and consult the process of generating product documentation & terminology
  • Facilitate the application and usability related knowledge transfer to leverage domain and context understand with appropriate trainings across the organization
  • Manage and support the establishment and continuous improvement of product specific trainings for the different user groups.
  • Support our marketing and sales teams throughout the market preparation activities with specific product, workflow and use environment knowledge for customer communication
  • Participation in and contribution to national and international standard committees e.g., IEC/VDE/DKE/
  • Contribute to post market surveillance and quality assurance activities
  • Foster interfaces and collaboration with Provider Business and Clinics
  • Support and collaborate in frontloading and pre-development activities providing expert know how and insights to real world application of in-center products

Your profile

  • Successfully completed Bachelor’s or Master’s degree, in the field of science, engineering or economics, alternatively dual vocational training in the technical or nursing field followed by several years of professional experience (specializing in the field of nephrology & dialysis, medical technology, usability engineering)
  • Several years of professional experience in the medical field and usability engineering
  • Detailed knowledge & experience in the field of chronic hemodialysis, renal replacement therapy & extracorporeal therapies and usability engineering
  • Extended knowledge in Usability Engineering Processes and corresponding regulatory environment
  • Knowledge of Requirement Engineering, Risk Management and Post Market Surveillance processes and their application
  • Profound problem-solving competency and cross-functional stakeholder management capabilities
  • In-depth (multi-)project management understanding and the ability to identify feasible methods for application
  • Exceptional social skills and competencies, especially cooperation, communication, conflict management and leadership
  • Strong and experienced manager, especially in indirect people management, can lead through influencing and convincing others rather than using direct authority
  • Experienced in functionally guiding and influencing management and project teams on a regular basis
  • Global mindset and willingness for occasional business trips
  • Fluent in German and English, both in written and spoken

Fresenius Medical Care North America

Website: https://fmcna.com/

Headquarter Location: Waltham, Massachusetts, United States

Employee Count: 10001+

Year Founded: 1996

Last Funding Type: Post-IPO Equity

Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical