Human Factor Design Engineer

WHO ARE WE

Decos digitizes the world. From our paper and management less offices, we work in self-managing teams, where you determine your goals and the ways in which you will achieve them. You will enjoy your coffee with your future colleagues.

We create IT solutions that allow you to work effectively and efficiently. We do this for governments as well as for private enterprises so that they can better tailor their services to the needs of their residents. For example, we are working on Smart Cities, with smart software that meets today’s contemporary digital needs. With beautiful web forms and easy apps, we try to make it so nice and simple for people that applying for an event permit or reporting storm damage is a breeze for everyone.

WE ARE LOOKING FOR

Human Factor Design Engineer

Must Have Skills:

• 3+ years of experience in writing medical device usability documentation (IEC 62366-1)
• Extensive knowledge of HFE requirements /standards
• Understanding of HFE principles in ergonomics, human computer/machine interface, and data collection / analysis methodologies.
• Experience with risk management activities applied by Human Factors to medical devices (e.g. UEA, AFMEA, UFMEA, URA techniques).
• Experience planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)
• Experience in perform human factors validation and verification of medical products
• Strong experience in designing workflows and software UI’s
  Good understanding of user centered design, heuristic evaluations, design of experiments, and statistical analysis.
• Excellent understanding of design requirements of development

Technical Requirements (Good to Have):

• Prior experience independently developing biological safety assessments for inclusion with regulatory submissions is preferred.
• Knowledge of standards for biocompatibility of breathing gas pathways in healthcare applications, e.g. ISO 18562, is preferred.
• Industry experience in medical device materials and product development is preferred.
• Experience in supporting regulatory submissions, namely 510ks, is preferred.
• Experience working with internal and external scientific standard organization (e.g. ISO/TC 194) is preferred.
• Experience of working on Agile projects
  
  Soft Skills (Must Have):

• Excellent communication & presentation skills
• Positive attitude towards learning/challenges/team/etc.
• Planning and organizational skills to prioritize and handle multiple tasks.

Responsibilities:

• Leading human factors engineering work and research for medical devices and regulated products with minimal supervision.
• Designing and executing tests to simulate product use for validating and verifying product performance, reliability, and usability.
• Actively participating on device programs to ensure sound human factors principles are considered and implemented.
• Collaborating with various team to develop product prototypes to explore and validate user interfaces and demonstration prototypes
• Drawing conclusions and making recommendations based on a variety of technical inputs.
• Solving human factors engineering problems with minimal assistance.

WHAT’S IN IT FOR YOU?

You receive the opportunity to work in an international environment in a fast-growing software company.

• A lot of room for personal initiative
• Plenty of opportunities for personal development
• A pleasant informal and inspiring work atmosphere
• Enthusiastic colleagues