Temporary Human Factors Engineer Compliance Lead (21-01266)
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:
- Minimum 8+ years’ of relevant experience in the field of Human Factors Engineering
- Bachelor’s degree in Human Factors Engineering
- Demonstrated understanding of clinical engineering centered design, design of experiments, and statistical analysis verbally and in written form
- Develops collaborative working relationships with a range of functions including, but not limited to R&D, Marketing, Quality, Regulatory and Clinical functions
- Strong communication and organization skills and ability to multi-task effectively within tight deadline
- Direct experience with FDA Class 2 regulated environment. Class III experience preferable.
- Ability to discern the key technical, commercial, and program influences from available ‘noisy’ information
- Prior experience with human factors analyses and designing and executing usability studies
- Ability to analyze existing systems and propose user experience enhancements.
- 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
- Support the examination and analysis of use errors in existing and new products and services
- Work collaboratively with other design disciplines and clinical engineering to take design from requirements to detailed specifications for consumption by various engineering disciplines
- European Union Regulatory submission experience
- Punctual and responsible. Comply with all applicable Corporate and Divisional Policies and perform other duties as assigned by the Management Team.
- Knowledge with gap assessment and gap closure activities for international regulatory bodies.
- Sustaining engineering experience.
- Excellent written and verbal communication skills.
How to Apply
Please send your updated resume to iris.chen@axelon.com461 total views, 0 today