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Human Factors Engineering Document Specialist (JP8305)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Human Factors Engineering Document Specialist (JP8305)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date:  3.2.2021
Note: Remote until COVID-19 restrictions are lifted. Must be on site M-F when the site re opens. Onsite Essential
3 Key Consulting is hiring a Human Factors Engineering Document Specialist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • This is expected to be a contract position within the Human Factors and Usability Engineering team, working 40 hrs/week.
  • The position is for 1 year; it may be renewed at the end of that time period.
  • Once Covid work restrictions subside and the client staff return to their sites, this position will be expected to work at the client’s Thousand Oaks, CA headquarters for all work hours (likely no sooner than mid-year 2021).
  • There is no relocation for this position.

    Job Description:
  • The Human Factors Engineer (HFE) Document Specialist is responsible for supporting document activities related medical device and combination product development.
  • The document specialist will support multiple development teams across early and late-stage combination product development, as well as lifecycle management activities.
  • As a key contributor within the human factors team, you will manage change control for development and on-market programs, providing an essential liaison between development, commercial, brand, quality, regulatory and other internal stakeholders.

Top Must have Skill Sets:
  • Bachelor’s degree and 2 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience.
  • Experience working in a regulated medical device setting, using enterprise electronic document tools to manage design history files.
  • Collaborating and understanding the various needs and requirements within engineering, design, quality, commercial and regulatory teams.
Day-To-Day Responsibilities:
  • Supports electronic document management activities related to early stage development, late stage development and lifecycle management.
  • Works closely with human factors, instructional design and other internal stakeholders to ensure that document issues are understood, communicated to the correct stakeholders, and decisions and plans are made to ensure that robust design history files are created and maintained.
  • Interfaces and converses with human factors, instructional design, mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines. Ensures that our teams are meeting the needs of our users, our programs, and the client in a timely manner.
Employee Value Proposition:
The client is a leader in the biological pharmaceutical space, The Human Factors Engineering team has exposure to range of products. The role will challenge the HFE Document Specialist on planning, managing, and collaborating with internal and external stakeholders.
Red Flags:
• Only academic experience
• Past experience exclusively in consumer or industrial product design
• No medical device or drug-device development experience
Interview Process:
Phone screen and 2 panel interviews
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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