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REMOTE Human Factors Engineer

Company: Planet Pharma
Location: Thousand Oaks
Posted on: June 9, 2021

Job Description:

The Human Factors Engineer (HFE) /Usability Engineer (UE) contractor is responsible for supporting HFE/UE planning, research, development of company drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. This person is expected to collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams. This person will support human factors research driving innovative, intuitive, and useful products. The HFE contractor will support project study design, methodology, data collection, root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, product validation in support of regulatory submissions.

Basic Qualifications:

Doctorate OR Masters degree and 3 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience OR Bachelors degree and 5 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience,

Preferred Qualifications: -

  • Medical device, combination product, non-combination product including small and large molecule experience including functional knowledge of applicable guidance, regulations and standards including: ISO 14971, ICH Q9, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.15
  • Master's degree in Human Factors Engineering (HFE), Usability Engineering, Mechanical Engineering, Biomedical or Systems Engineering and 3+ years of industry experience, medical devices or combination products, non-combination product including large and small molecule products working in a matrixed and fast-paced corporation
  • Experience in front-end feasibility phase, exploratory research, user needs translation, ideation concept evaluations, device user interface evaluations, iterative design process, requirements and specification development, risk assessments, and formative testing
  • Experience supporting or leading various HF methodologies such as planning, coordinating, conducting, analyzing and reporting ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies
  • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines
  • Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience
  • The position requires good oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products

Keywords: Planet Pharma, Thousand Oaks , REMOTE Human Factors Engineer, Other , Thousand Oaks, California

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