[Hiring] Human Factors Engineer @3 Key Consulting

Role Description

In this vital role you will be responsible for supporting HFE/UE planning, research, development and continuous improvement of client 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.

The Human Factors Engineer / Usability Engineer (HFE/UE) is expected to collaborate with internal and external partners and across functions including engineering, design, commercial, safety, risk, quality, regulatory and market surveillance teams. This person will support human factors research driving innovative, intuitive, and useful products. The HFE will support project study design, HFE/UE methodology, study moderation, data collection, and root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, and product validation in support of regulatory submissions.

Qualifications

• Master’s degree in Human Factors Engineering, Usability Engineering, or related Psychology and/or Industrial Design domains plus at least 1-2 years’ experience working in the regulated medical device and/or biotech industry.
• OR Bachelor’s degree and at least 2-3 years of Human Factors Engineering/Usability Engineering experience working cross-functionally in the regulated medical device and/or biotech industry.

Requirements

• End to end human factors experience required from planning to validation and reporting.
• Must be able to demonstrate good technical writing skills.
• Good communication skills and experience working with cross functional teams.
• Minimum experience needed with medical device but most importantly combination product experience.

Benefits

• Unique industry opportunity.

Interview Process

• Candidate has a 25 minute phone interview with hiring manager.
• Candidate sends HFE writing example (redacted) to hiring manager.
• Candidate has a 50 minute panel interview.
• Candidate CV and panel interview results reviewed with senior leadership team.
• Decision to hire.