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Engineer II
Ref No.: 20-02698
Location: San Francisco, California
Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
 
Title: Human Factors Engineer
Duration: 1 year (could get extended or perm)
Location: South San Francisco (Remote for now)
 
Description:
  • Provides human factors engineering expertise to project teams developing combination product drug delivery devices, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered.
  • Collaborates with multi-functional teams including Device Engineering, Regulatory, Clinical, Quality, Marketing, and Program Management to inform and guide development of innovative products and ensure that those products are safe and easy to use.
  • As part of product development, conducts human factors engineering activities within device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies.
  • Develops instructions for use and training materials for clinical trial and commercial purposes.
     
    Qualifications
     
    The right candidate will possess the following skills and experience. The level of the position will depend on the qualifications of the selected candidate.
  • Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Mechanical Engineering, or related discipline.
  • 2+ years of relevant experience in the pharmaceutical, biotech or medical device industry, or an advanced degree in a relevant discipline; 5+ years of experience required for the Engineer II level.
  • Ability to write formative and summative usability study protocols and reports, and author human factors summary reports consistent with health authority expectations. This experience is required for the Engineer II level.
  • Ability to work cross-functionally on risk management activities.
  • Ability to design instructions for use (IFU) documents and training materials for medical devices/combination products and conducting usability testing of them. This experience is required for the Engineer II level.
  • Experience interfacing with external consultancies, or as part of an external consultancy team that supports the design and development of new medical devices is required for the Engineer II level.
  • Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics.
  • Proven ability to clearly communicate how study results can be implemented into design.
  • Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combinations products preferred.
  • Ability to communicate effectively in writing, verbally, and as a presenter.
  • Demonstrated time management, decision making, presentation, and organization skills.