Senior Human Factors & Systems Engineer

Description:

SUMMARY: Join our team as a Senior Systems Engineer and play a pivotal role in the design and development of innovative medical devices and systems. This position blends Human Factors Engineering (HFE) and Systems Engineering to create products that prioritize usability, safety, and effectiveness, enhancing patient outcomes and healthcare experiences. From early concept design to post-market activities, you’ll lead cross-functional initiatives, manage risk, and ensure compliance with global medical device regulations, all while championing user-centered design principles.

What you’ll get to do:

Systems Engineering
• System Design & Integration: Develop and integrate complex medical device systems, ensuring seamless interaction between software, hardware, and digital health technologies.
• Prototype Development: Collaborate with multidisciplinary teams to design, test, and refine prototypes using cutting-edge technologies and methodologies.
• Testing & Validation: Lead the creation of robust test plans to validate system components and ensure they meet performance and quality standards.
• Risk Management: Conduct and lead activities such as FMEA, root cause analysis, system hazard analyses, and technical risk triage.
• Safety Standards Compliance: Ensure product adherence to relevant safety standards (e.g., IEC 60601, ISO 14971) and medical device regulations.
• Technical Leadership: Provide systems engineering expertise to guide project teams, identify risks, and drive successful outcomes throughout the product lifecycle.

Human Factors Engineering (HFE)
• User-Centered Design: Conduct formative and summative usability studies for hardware, software, labeling, and disposables, ensuring compliance with FDA and international HFE standards.
• Cross-Functional Leadership: Act as the organization’s expert on HFE topics, guiding teams in areas such as heuristic evaluation, user interface design, and qualitative data analysis.
• Process Development: Develop and implement HFE processes and procedures aligned with industry best practices to optimize product usability and safety.
• Mentorship: Mentor and provide technical guidance to less experienced engineers, fostering growth in HFE capabilities across the organization.

Collaboration & Communication
• Partner with R&D teams to evaluate and validate product prototypes, ensuring user needs are at the forefront of design decisions.
• Present findings and recommendations from usability studies to stakeholders through clear, concise reports and presentations.
• Drive harmonization of system architecture and the reuse of design/test practices across product lines to enhance efficiency and consistency.

Continuous Improvement
• Stay at the forefront of emerging trends in human factors engineering, usability, and user experience design.
• Participate in quality improvement initiatives, complaint investigations, and safety assessments to ensure continuous enhancement of products and processes.

Basic Qualifications:

Education:
• Bachelor’s degree in Human Factors Engineering, Systems Engineering, Applied Psychology, Industrial Engineering, or a related field (Master’s or PhD preferred).

Experience:
• Minimum of 6-8 years of professional experience in human factors and systems engineering, with a strong background in HFE principles and methodologies.
• At least 5 years in the medical device industry required, with a deep understanding of applicable quality and safety standards (e.g., ISO 13485, FDA QSR, EU MDR).
• Proven track record of leading HFE projects with high complexity and scope.
• Experience in risk management processes (e.g., CAPAs, DHF remediation, requirements traceability).