Principal Scientist, Human Factors

Job Description

The Human Factors team plays a pivotal role in combination product development (both design and process) commercialization and lifecycle management. This person will lead and manage human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products and medical devices in our Companys portfolio and pipeline including acquisition products.

This position will interact extensively with all subject-matter experts within the Device Development team as well as with members of numerous internal cross-functional product development teams from concept through product launch and post-market surveillance.

Key Responsibilities and Activities:

• Coach and mentor junior scientists fostering their professional growth and development within the organization.

• Lead Human Factors Project Work (Strategy and Execution) including but not limited to

• Own HF strategy from early concept through validation and post-market for devices and combination products.

• Build HF plans and study roadmaps; select methods (user research task/use-error analysis risk mitigation formative/summative usability testing).

• Turn user insights into design inputs for device UI packaging labeling and IFU; guide intuitive safe designs.

• Partner with marketing program management clinical safety regulatory manufacturing packaging and labeling to integrate HF and manage risk.

• Lead regulatory deliverables: HF protocols/reports linkage to risk management (ISO 14971) hazard/use-related risk analyses and submission materials (FDA EU MDR).

• Maintain compliant HF documentation and traceability; ensure audit readiness.

• Monitor post-market use-related issues and drive corrective actions and training.

• Lead Human Factors Project Work (Strategy and Execution) including but not limited to

• Define and continuously improve HF process standards and templates per IEC 62366-1 and FDA guidance.

• Set clear governance (gates criteria documentation) for consistent HF quality across programs.

• Create reusable methods for needs discovery user profiling task analysis and use-related risk assessment.

• Provide portfolio-level guidance for UI labeling and IFU to reduce use-related risk.

• Train cross-functional teams on HF practices and compliant documentation.

• Establish metrics and feedback loops (study quality defects post-market signals) to prioritize improvements.

• Maintain centralized HF libraries and tools to enable reuse and speed development.

Qualifications:

• B.A./B.S in Human Factors Ergonomics Cognitive or Experimental Psychology Sociology Engineering Chemistry or Business Management plus 15 years of related experience.

• Strong knowledge of human factors device regulatory requirements and industry standards related to device systems.

• Prefer to have experience in team and people management.

• Excellent communication leadership and problem-solving skills.

• Ability to work in a dynamic and fast-paced environment managing multiple priorities effectively.

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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