Senior Principal Engineer, Human Factors

CSL Behring Vifor seeks a Senior Principal Engineer to lead Human Factors Engineering within the Drug Delivery Systems & Packaging department in EMEA/CH.

This position sits within the Drug Delivery Systems & Packaging (DDSP) team under CSL Technical Operations. The department is shifting its focus toward front-end development, moving away from primarily executing formative and summative studies. The role requires a professional with a strong history in developing drug delivery devices, covering the entire lifecycle from initial concept through to commercialization and ongoing product maintenance.

Responsibilities

• Serve as the Lead Human Factors Engineer for the team.
• Manage and carry out Human Factors Engineering tasks for drug delivery projects, including secondary packaging and Instructions for Use.
• Establish and enforce best practices for Human Factors Engineering across the DDS&P group.
• Standardize methodologies for Task Analysis, Use Risk Assessment, and other essential deliverables.
• Oversee the development of secondary packaging from a Human Factors perspective.
• Collaborate with project leads and cross-functional teams on project planning and execution.
• Define selection criteria and evaluate user interfaces for new products.
• Gather, maintain, and apply data regarding user capabilities and known use problems with combination products.
• Contribute to the creation of Company Core Data Sheets (CCDS).
• Plan and conduct Formative and Summative evaluations, including the selection and oversight of Contract Research Organizations (CROs).
• Prepare dossier submissions for Human Factors content, such as HFE/UE Reports, and address regulatory agency inquiries.
• Keep abreast of industry trends, standards, and regulatory guidance.

Requirements

• Strong communication skills and experience working in a matrix environment.
• Capacity to influence and promote a culture of continuous improvement.
• Expert knowledge of the IEC 62366 standard family and related regulatory guidance.
• Expertise in User Capabilities, particularly anthropometric bases.
• Expertise in conducting Use Risk Assessments.
• Proven experience evaluating user interfaces for drug delivery devices.
• Proven experience developing instructional materials for product labeling and artwork.
• Relevant academic qualification in Ergonomics, Psychology, Science, or Engineering.
• Minimum of 8 years of relevant experience in the pharmaceutical or medical device industry.
• Willingness to travel internationally up to 20% of the time.

What the company offers

• Access to information regarding CSL benefits and well-being support.

About the company

CSL Behring is a global leader in biotherapeutics, driven by a mission to save lives. The company leverages three strategic scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. It operates one of the world’s largest plasma collection networks, CSL Plasma. Inclusion and Belonging are central to the company's mission, fueling innovation, while a culture of curiosity and empathy helps the organization better understand patients and donors.

• Inclusion and Belonging are core to the mission and drive innovation.
• The company fosters a culture of curiosity and empathy to understand patients and donors.
• CSL Behring is a global biotherapeutics leader driven by the promise to save lives.