Global Lead, Human Factors & Usability Strategy

CSL Vifor; Bern; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Flexible working arrangements

Professional development

Competitive compensation

Zusammenfassung

CSL Vifor in Switzerland seeks an Associate Director of Human Factors Design and Development to drive global HF strategies for medical devices and healthcare technologies. You will lead cross-functional teams, embed HF throughout the product lifecycle, and ensure usability and safety inform product concepts and regulatory submissions.

The role requires 8–12 years in HF engineering, advanced degrees, and deep knowledge of ISO 14971, IEC 62366, and FDA guidance.

Qualifikationen

• Master’s or PhD in Human Factors, Industrial Design, HCI, Ergonomics, Biomedical Engineering, or a related field.
• 8–12 years of experience in human factors engineering, usability, or related product development.
• Experience in medical devices, combination products, or healthcare technologies.
• Proven experience conducting formative and summative usability studies.
• Knowledge of human factors standards (IEC 62366, FDA guidance, ISO 14971).
• Expertise in human factors and usability engineering.
• Strong understanding of design controls and risk management.
• Experience with usability study design, execution, and analysis.
• Regulatory knowledge for HF submissions and compliance.
• Cross-functional collaboration and project leadership.
• Excellent written and verbal communication skills.

Aufgaben

• Develop and implement global human factors strategies for product design and development.
• Identify critical user interactions, use environments, and potential risks impacting safety and efficacy.
• Integrate human factors early in the design process to minimize risk and optimize usability.
• Lead human factors design inputs, design controls, and usability engineering throughout the product lifecycle.
• Guide interface design, labeling, and user instructions to improve user experience.
• Collaborate with R&D, Engineering, and Product Development teams to ensure HF considerations are incorporated into product concepts and prototypes.
• Conduct human factors risk assessments in alignment with ISO 14971 and company risk management procedures.
• Plan and execute formative and summative usability studies.
• Analyze study data to identify usability issues and recommend design modifications.
• Document human factors and usability validation activities for regulatory submissions.
• Support preparation of HF-related sections of regulatory submissions (FDA, EU MDR, and other global authorities).
• Ensure HF programs meet all relevant international standards and guidance.
• Serve as a subject matter expert for regulatory inspections related to human factors.
• Partner with Clinical, Regulatory, Quality, and Manufacturing teams to ensure integrated design development.
• Mentor and develop junior HF staff.
• Participate in project planning, milestone reviews, and senior leadership meetings.

Kenntnisse

Human Factors

Usability Engineering

Regulatory Knowledge

Cross-functional Leadership

Study Design

Risk Management

ISO 14971

IEC 62366

Medical Devices

Regulatory Submissions

Communication

Ausbildung

Master’s or PhD in relevant field

Tools

HF Design Tools

Jobbeschreibung

CSL Vifor in Switzerland seeks an Associate Director of Human Factors Design and Development to drive global HF strategies for medical devices and healthcare technologies. You will lead cross-functional teams, embed HF throughout the product lifecycle, and ensure usability and safety inform product concepts and regulatory submissions.

The role requires 8–12 years in HF engineering, advanced degrees, and deep knowledge of ISO 14971, IEC 62366, and FDA guidance.