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Human Factors Engineer, Biotech Medical Device - REMOTE (JP11933)

Posted 77 weeks ago
All others
Contract
United States
W2 $55 - $75/hour

Overview

The Human Factors Engineer (HFE) / Usability Engineer (UE) contractor is responsible for supporting HFE/UE planning, research, and development of drug delivery devices using best practices in accordance with current regulations and guidelines within the medical device, combination product, and bio-pharmaceutical industries.

In Short

  • Work collaboratively with HFE, engineering, design, commercial, and product teams.
  • Support usability activities such as planning, protocol development, and study management.
  • Analyze data from usability studies to inform design and risk minimization.
  • Prepare documentation for development activities and regulatory submissions.
  • Communicate with internal and external stakeholders.
  • Lead HFE studies including planning and reporting.
  • Author end-to-end HFE documents for regulated medical devices.
  • Ensure successful translation of user requirements into products.
  • Support human factors research driving innovative products.
  • Collaborate across engineering, design, and regulatory teams.

Requirements

  • Master’s degree in Engineering or Bachelor’s degree with 2 years of experience.
  • 4+ years of human factors engineering experience preferred.
  • Experience in technical writing and communication.
  • Ability to work autonomously and critically analyze data.
  • Detail-oriented with strong collaboration skills.
  • Experience with medical devices and regulatory submissions.
  • Knowledge of HFE best practices.
  • Experience leading usability studies.
  • Strong problem-solving skills.
  • Ability to prepare comprehensive documentation.

Benefits

  • Opportunity to work with a leading global biotechnology company.
  • Remote work flexibility.
  • Potential for contract extension or conversion to full-time employment.
  • Engagement in innovative product development.
  • Collaboration with cross-functional teams.
  • Professional growth in the biotech field.
  • Competitive hourly rate.
  • Exposure to regulatory processes in medical devices.
  • Supportive work environment.
  • Access to industry-leading practices and methodologies.
3 Key Consulting logo

3 Key Consulting

3 Key Consulting is a dynamic consulting firm specializing in providing expert engineering and technical support to the biotechnology and pharmaceutical industries. With a focus on innovative solutions, the company partners with leading global biotechnology firms to enhance their manufacturing processes and operational efficiency. 3 Key Consulting is committed to delivering high-quality services, including the development and validation of electronic batch records, and is currently seeking skilled professionals to join their team in various capacities.

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