Human Factors Engineer, Biotech Medical Device - REMOTE

Human Factors Engineer, Biotech Medical Device - REMOTE

3 Key Consulting is recruiting a Human Factors Engineer for 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 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 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 and methodology. This person will lead study data collection, 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 regulatory submissions.

Top Must Have Skill Sets:

• Author end-to-end 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 client's 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:

• Master's degree in Engineering OR
• Bachelor's degree in Engineering and 2 years of experience

Preferred Qualifications:

• Bachelor's 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 30-min VC interview. Following phone interview, 1-2 group interviews lasting 45-min VC interview. Discussion with senior leadership and director of HFE. Decision to hire or not.