Senior Principal Engineer, Human Factors

About the role

This role is a position in the Drug Delivery Systems & Packaging (DDSP) department within CSL Technical Operations. The ideal candidate has a solid track record in the development of drug delivery devices, from concept development through commercialization and product maintenance. This role requires experience in leading user interface development and a passion for making the right product that meets the needs of the patients.

Responsibilities

• Act as Lead Human Factors Engineer
• Plan and execute Human Factors Engineering activities in drug delivery device projects, including development of secondary packaging and Instructions for Use
• Set and drive best practices within DDS&P for Human Factors Engineering
• Support standardization of approaches for Task Analysis, Use Risk Assessment, and other key deliverables
• Lead HF oversight of secondary packaging development
• Partner with project leads and the cross-functional development team on planning and execution of projects
• Lead development of selection criteria and evaluation of the user interface for new products
• Collect, maintain, and utilize data on user capabilities and known use problems with combination products
• Contribute to the development of Company Core Data Sheets (CCDS)
• Plan and execute Formative and Summative evaluations, including selection and oversight of CROs
• Leverage existing data to support regulatory submissions, e.g., comparative analysis
• Develop dossier submissions for HF content, including HFE/UE Report, and responses to regulatory agency questions
• Monitor industry trends, standards, and regulatory guidance
• Excellent communication skills and a track record working in a matrix environment
• Ability to influence and promote a culture of continuous improvement
• Subject Matter Expertise on:
• IEC 62366 family of standards and related regulatory guidance
• User Capabilities – anthropometric basis
• Use Risk Assessments

Requirements

• Proven track record of:
• Evaluation of user interfaces for drug delivery devices
• Development of instructional materials for product labelling and artwork
• Relevant academic qualification in an appropriate field, e.g., Ergonomics, Psychology or a suitable Science or Engineering degree
• At least 8 years of related experience in the pharmaceutical or medical device industry
• Ability to travel internationally up to 20%

Qualifications

• At least a Bachelor's Degree

Skills

• Strong understanding of IEC 62366 family of standards and related regulatory guidance
• Expertise in user capabilities and anthropometric basis
• Proficiency in conducting Use Risk Assessments

Benefits

To learn more about CSL benefits visit How CSL Supports Your Well-being | CSL.

Pay

N/A

Schedule

N/A