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Human Factors Engineering

Description

Phillips-Medisize A/S is an expert in the design, development, and delivery of advanced drug delivery devices and connected health solutions. The customers are leading pharmaceutical companies worldwide. Phillips-Medisize A/S is a part of Phillips-Medisize the Pharmaceutical and Medical Division of Molex. The company offers innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Read more about Phillips-Medisize A/S at phillipsmedisize.com

In this position, you will be growing your potential as the Senior Human Factor Engineering (HFE), at Phillips-Medisize in Struer or Virum. You will have an opportunity to have a close collaboration with Front End Sales, Project Managers, Project Teams, vendors, and our customers.

You will contribute to all stages of the product development model and participate in the design of user interfaces to secure safe and effective interaction. The Human Factor Engineer executes planning and managing formative and summative usability studies according to best practice.

Do you want to design safe and reliable medical devices, helping patients to better treatment?

Do you want to cooperate with highly skilled colleagues in complex cross-functional development projects to bring new products to the market in a fast-growing and successful global company?

Are you ready to join a small team of dedicated and highly qualified Human Factor Engineers

Sounds like you? Then please find the detailed description below.

What You Will Do In Your Role

  • Work in close collaboration with Front End Sales, Project Managers, Project Teams, vendors, and our customers to fulfill the expectations and requirements timely
  • Contribute in all stages of the product development model – from initial ideas to the summative study and submission of documentation
  • Participate in the design of user interfaces to secure safe and effective interaction
  • Plan and manage formative and summative usability tests according to best practice
  • Produce and compile Human Factor Engineer (HFE) design history files for submission according to regulatory requirements and myQMS
  • Interact with Quality Assurance and regulatory bodies
  • As a subject matter expert work independently and take full responsibility for Human Factors activities in your projects
  • Support the projects in planning and budgeting the HFE activities
  • Contribute to the continued development of the HFE Team and competency area in Denmark and within Phillips-Medisize

The Experience You Will Bring

Requirements:

  • You should have a senior experience in Usability/ Human Factors Engineering from working within the business of medical devices or pharmaceuticals
  • We require a working knowledge of medical device development processes, design controls, and guidelines like ANSI/AAMI IEC62366-1, ISO 14971, FDA guidance “Applying Human Factors and Usability to Medical Devices
  • Proven experience in compiling engineering documents related to usability engineering for regulatory submissions. Like the User requirements specification, Task Analysis, Usability test protocols, and the HFE Report
  • Experience in developing Graphical User Interface-flow and other visual interfaces.
  • Practice in planning, conducting, and reporting formative and summative studies
  • Bachelor, Master degree or Ph.D. in Engineering, human factors, cognitive psychology, behavioural science, or similar qualifications

What Will Put You Ahead

  • Proven experience with Medical Device development involving Electronics, Mechanics, and Software
  • Experience in developing Instruction for Use, Quick Reference Guide, and packaging
  • Familiar with tools like Adobe XD
  • Previous interaction with vendors
  • HFE knowledge of developing Apps
  • A self- managing, proactive and outgoing personality with cooperative approach

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