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Date Added: Sat 25/12/2021

Human Factors Engineer - Medical Devices & Combination Products

Italy / Germany, Germany
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Company: HAYBURY

Job Type: Permanent, FullTime

A reputable and global organisation within the pharmaceutical industry is seeking a Risk Management Lead to create and implement risk management processes within their rapidly evolving medical device/ combination product division. This is a true opportunity to innovate and make a mark within organisation.

 

(Senior) Human Factors Engineer:

  • Conceptualising new products by defining user requirements and translating user requirements into design solutions and optimal user experiences 
  • Define and implement a human factors engineering process in accordance with IEC 62366 and ISO14971. Integration of this process into the SG product development process for DDS  
  • Develop and execute the HFE plans for first-class usability according to the requirements of medical device regulators around the world (FDA HFE Guideline, IEC 62 366, ANSI / AAMI HE 75) 
  • Carrying out user research, analysing and characterising the usage-related risks and carrying out or carrying out usability tests on the products with internal or external partners 
  • Leadership role in the preparation of task analyses, user risk analyses, implementation of formative and summative evaluation studies and ensuring that the usability engineering files are complete and correct and can be approved by the regulatory authorities for medical devices / combination products 

 

 Required capabilities: 

  • Completed degree in biomedical engineering, design, HCI, HFE, psychology or other similar fields 
  • Several years of professional experience in the HFE and ideally in the development of medical products 
  • Ability to design medical devices and to lead usability engineering activities (i.e. definition of usability requirements, creation of usability risk analyses, study protocols and study reports) for a complex mechanical and also software-controlled electromechanical medical device as a drug delivery system 
  • Ability to apply user-centred design and usability engineering principles to product research, development and design 
  • Ability to collaborate and communicate with various groups and levels of management within the company, including other engineering groups, marketing, clinical applications and regulatory affairs 
  • Experience with all phases of the product development life cycle within the medical device industry under a strong QMS 
  • Experience in creating medical device usability deliveries according to IEC 62 366 
  • Good knowledge of the applicable standards: ISO 13 485, ISO 14 971, IEC 62 304 
  • Organisational skills  
  • Ability to work both independently and in a collaborative team 
  • Experience in working with doctors, clinicians, laboratories or in hospitals is desirable 
  • Experience with parenteral drug delivery systems, handheld and wearable devices is desirable 
  • Business fluent English and German, spoken and written 

 

This role will give you the opportunity to:

  • Receive a competitive salary and remuneration package
  • Truly impact and innovate risk management processes within a growing division
  • Find clear pathways for career progression and professional development

 

If you have the expertise and experience for this opportunity and the ambition to take on this position, please call Jess for further details or email your CV today.

Contact Jess on - phone: +44 01273 059 641 / #removed#    email: #removed#

Jess is a Senior Search Consultant at Haybury Search covering Europe, UK, North America, and Asia.

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