Senior Human Factors Engineer

Why Join Bracco Medical Technologies?

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!

The Senior Human Factors Engineer plays a critical role at Bracco Medical Technologies to ensure the safe, effective, and intuitive use of medical devices. This role leads human factors activities across the product lifecycle—from early research through commercial launch—by applying user-centered design principles, usability engineering, and regulatory-compliant methodologies. The ideal candidate is highly collaborative, comfortable working in cross-functional technical teams, and experienced in developing medical devices under FDA, IEC, and international human factors and usability standards.

• Develops and maintains the Human Factors Plan for a medical device in alignment with technical strategy set by the Principal Human Factors Engineer.
• Develops the product Use Specification to identify product user groups and use environments.
• Supports the development of Stakeholder Needs and translates those needs into usability requirements.
• Performs Task Analysis to understand and design the use of a product.
• Performs Use-Related Risk Analysis to identify potential use errors and mitigations.
• Develops and prototypes product user interfaces to investigate design choices with representative users.
• Develops formative study protocols/plans, oversees the execution, and reports the results.
• Develops summative study protocols/plans, oversees their execution, and reports the results.
• Develops and maintains the Human Factors Summary Report to support submission to FDA and other regulatory and/or notification bodies.
• Develop, coach, and mentor junior team members, supporting their professional growth.
• Support the continuous improvement of Quality Management System (QMS) procedures that govern Human Factors Engineering activities.
• Partner with Principal Engineers to develop significant and impactful Intellectual Property to fuel the growth of the business.
• Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS), including development and maintenance of documentation.

Required

• Bachelor's degree in Human Factors Engineering, Usability Engineering, Industrial Design, or other scientific discipline, preferably systems, electrical, mechanical, or software.
• Bachelor's degree with a minimum of five (5) years of relevant experience or Master's degree with a minimum of three (3) years of relevant experience.
• 3 years' of experience with new product development product usability.
• Demonstrated knowledge skills and abilities in integrating human factors throughout the product development lifecycle.
• Experience performing quantitative and qualitative research methods.
• Experience supporting software and/or hardware user interface design.
• Experience developing all materials necessary to comply with Human Factors Engineering expectations of FDA and other regulatory bodies.
• Knowledge of standards specific to Human Factors Engineering (FDA guidance, IEC 62366, HE75).
• Ability to grow productive, trusting, and open relationships with internal stakeholders.
• Strong interpersonal and communication skills, with the ability to interface with customers in a professional manner.
• High degree of organizational skills and high attention to detail.
• Ability to work independently to plan, schedule, and execute activities necessary to meet project timelines.

Preferred

• Graduate degree in Human Factors Engineering, Usability Engineering, Industrial Design or another relevant scientific discipline.
• Board certification in Human Factors or Professional Ergonomics.
• 3+ years exposure to medical device quality systems.
• 5+ years product development experience.
• User interface design experience and prototyping skills.
• Experience working with physicians and customers in a medical device product development role.
• Awareness and working knowledge of system-level…