Who ❤️ PJ →

Full Search

This job listing has expired and may no longer be relevant!
18 Jan 2021

Temporary Human Factors Engineer Compliance Lead (21-01266)

Axelon Services Corporation – Posted by iris.chen@axelon.com Plano, Texas, United States

Job Description

Long Term Contract for a Human Factors Engineer (no corp. to corp. or 3rd party)

Work independently in a lead  Human Factors Engineering role for Compliance Submissions  Develop cross-functional working relationships, communicate efficiently, lead technical reviews and provide effective communication to Senior Management.
Mandatory Skill/Experience:

  1. Minimum 8+ years’ of relevant experience in the field of Human Factors Engineering
  2. Bachelor’s degree in Human Factors Engineering
  3. Demonstrated understanding of clinical engineering centered design,  design of experiments, and statistical analysis verbally and in written form
  4. Develops collaborative working relationships with a range of functions including, but not limited to R&D, Marketing, Quality, Regulatory and Clinical functions
  5. Strong communication and organization skills and ability to multi-task effectively within tight deadline
  6. Direct experience with  FDA Class 2 regulated environment. Class III experience preferable.
  7. Ability to discern the key technical, commercial, and program influences from available ‘noisy’ information
  8. Prior experience with human factors analyses and designing and executing usability studies
  9. Ability to analyze existing systems and propose user experience enhancements.
  1. Experience with all aspects of human factors practice including: literature survey,  developing research plans and test protocols, conducting formative and summative usability testing research, and regulatory documentation
  2. Support the examination and analysis of use errors in existing and new products and services
  3. Work collaboratively with other design disciplines and clinical engineering to take design from requirements to detailed specifications for consumption by various engineering disciplines
  4. European Union Regulatory submission experience
  5. Punctual and responsible. Comply with all applicable Corporate and Divisional Policies and perform other duties as assigned by the Management Team.
  6. Knowledge with gap assessment and gap closure activities for international regulatory bodies.
  7. Sustaining engineering experience.
  8. Excellent written and verbal communication skills.
Share this role online (there may be a referral fee*)

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

461 total views, 0 today

Apply for this Job