Senior Principal Engineer, Human Factors

Job summary

This position is within the Drug Delivery Systems & Packaging department, focusing on the development of drug delivery devices from concept to commercialization. The role emphasizes user interface development and aims to enhance the Human Factors Engineering team's capabilities.

Qualifications

• Strong communication skills and experience in a matrix environment.
• Ability to influence and foster a culture of continuous improvement.
• Expertise in IEC 62366 standards and related regulatory guidance.
• Proven experience in evaluating user interfaces for drug delivery devices and developing instructional materials.
• Relevant degree in Ergonomics, Psychology, or a related Science or Engineering field.
• Minimum of 8 years of experience in the pharmaceutical or medical device industry.
• Willingness to travel internationally up to 20%.

Responsibilities

• Lead Human Factors Engineering activities in drug delivery device projects.
• Plan and execute evaluations for secondary packaging and Instructions for Use.
• Establish best practices for Human Factors Engineering within the department.
• Standardize approaches for Task Analysis and Use Risk Assessment.
• Oversee secondary packaging development and user interface evaluation for new products.
• Collect and utilize data on user capabilities and known issues with combination products.
• Develop submissions for regulatory content and respond to agency inquiries.
• Stay updated on industry trends, standards, and regulatory guidance.

Skills

• Strong analytical and problem-solving skills.
• Proficient in user-centered design principles.
• Experience with regulatory submissions and compliance.

Education

• Relevant academic qualification in Ergonomics, Psychology, or a suitable Science or Engineering degree.

Tools

• Familiarity with user interface design tools and methodologies.