Job Title:Human Factors Engineer Biotech Medical Device REMOTE (JP11933 Location:Thousand Oaks CA.REMOTE) Business Unit:Combination Product Excellence Employment Type: Contract Duration:1 years with possible extensions or conversion to FTE Rate: W2 $55 $75 or Market Rate Posting Date:10/24/2023
3 Key Consulting is recruiting aHuman Factors Engineerfor a consulting engagement with our direct client a leading global biotechnology company.
Job Description: Manager would like to see writing samples if available.
Successful candidate understands human factors engineering and has 4 YOE prior HFE experience (not including academic. this must be industry experience). Ability to work autonomously. Is a critical thinker detail oriented and a great communicator. Manager prefers Bachelors or greater in human factors engineering or biomedical engineering or mechanical engineering.
Description: The Human Factors Engineer (HFE) / Usability Engineer (UE) contractor is responsible for supporting HFE/UE planning research development of drug delivery devices using HFE/UE best practicesand in accordance with current regulations and guidelines within the medical device combination product and biopharmaceutical industries. This person is expected to collaborate with internal and external partners and across engineering design commercial quality andregulatory teams. This person will support human factors research driving innovative intuitiveand useful products. The HFE contractor will support project study design and methodology. This person will lead study datacollection root cause analysis and report writing to inform design and apply sound HFE/UE knowledge and experience to research development clinical studies product validation in support of regulatorysubmissions.
Top Must Have Skill Sets:
Author endtoend HFE documents for regulated medical devices;
Superb technical writer and communicator; and
Experience leading HFE studies including planning writing protocols moderating note taking analyzing and reporting.
Day to Day Responsibilities:
Work collaboratively with HFE engineering design commercial and product teams to ensure successful translation of user requirements into products to create user interface (UI) requirements that meet the needs of users and enrich the overall user experience across clients portfolio or programs.
To support usability activities such as planning protocol development data collection sheets moderator scripts material development study coordination IRB submissions participant recruitment study management.
Analyze objective and subjective data from usability studies to inform design inform risk minimization and provide alternative solutions.
Prepare documentation to support development activities design controls DHF DMR including protocols task analysis risk assessment HFE technical assessments HFE reports and regulatory submissions.
Actively communicate with internal and external key stakeholders.
Basic Qualifications: Masters degree in EngineeringOR Bachelors degree in Engineering and 2 years of experience
Preferred Qualifications: Bachelors degree in Engineering and 4 years of experience
Why is the Position Open Supplement additional workload on team
Red Flags:
University graduate work does not contribute to years worked.
Less than 4 years of human factors medical device or combination product work experience.
Moves between jobs frequently.
Interview Process: Hiring team will review resumes and identify candidates for initial 30min VC interview. Following phone interview 12 group interviews lasting 45min VC interview. Discussion with senior leadership and director of HFE. Decision to hire or not.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
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