The Human Factors Principal Engineer position is a key technical leadership role at Bracco Medical Technologies (BMT) and has responsibility for shaping the definition, design, and evaluation of Bracco’s medical products. You will lead human factors and usability engineering activities throughout the product development lifecycle, working closely with cross-functional teams to design and validate user-centered solutions. You will be responsible for developing the human machine interface of our devices to positively impact the safety and efficiency of the clinician and patient. You will study and identify key properties of the user and patient workflows and design an efficient way to implement an optimal interface to impact the user-patient experience. This position typically overlaps many technical and human-centered disciplines, including industrial engineering, functional engineering, clinical affairs, and marketing. You will partner with the marketing team to engage in customer research to understand needs as well as the Clinical team to ensure the workflow optimizes the needs of the user and patient. Strong ties with System Engineering is also required to ensure proper user requirements are documented with drive the design of our devices. In this role, you must demonstrate a keen ability to facilitate cross-functional collaboration.
Primary Duties and Responsibilities:
- Understand the clinical domain and technical knowledge of BMT systems and devices to provide Human Factors support to the development of medical devices.
- Lead the planning, execution, and reporting of human factors engineering activities across product lifecycle.
- Apply human factors principles and techniques to influence the design, development, and evaluation of medical devices across the product lifecycle, including:
- Ethnographic user research to identify user profiles and their needs.
- Support the translation of user needs to design requirements and to product design concepts.
- Develop user interface prototypes through iterative usability testing to explore and validate product design concepts.
- Performing workflow, task, and use error analysis.
- Ensuring human factors principles are considered and implemented.
- Identify user groups, environments, use scenarios and critical tasks for task analysis, instructions, guides, user training and system verification and validation.
- Engage with cross functional team to develop User Needs Requirements that drives design decisions within relevant clinical environments.
- Own the Usability engineering plan for each product and standardize basic workflows as a proprietary branding for Bracco devices.
- Develop protocols, conduct system tests and write reports, i.e., usability engineering plans, Task analysis, Use Error Analysis, Requirements Development, usability protocols, formative & summative execution plans, and validation tests in cooperation with clinical and marketing partners.
- Resolve technical challenges by providing technical guidance to the product and engineering team through rigorous trade-off analysis to create robust and effective solutions.
- Analyze and author the reports from summative/formative testing and Human Factors/Engineering Summary report.
- Partner with the functional technical leaders (Architects/Principals) to develop significant and impactful Intellectual Property around clinical workflow 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
- Develops products that meet requirements regulated by FDA, UL, CE, and other governing bodies as defined by product management.
- Mentor and provide guidance to junior human factors engineers.
- Commit to fostering and driving an environment and work output based on continuous improvement
Required Skills
Required
- Bachelors’ degree in Human Factors Engineering, Usability Engineering, or other scientific discipline, preferably systems, electrical, mechanical, or software.
- 5+ years of engineering experience.
- 3-5 years new product development product usability
- 3+ years exposure to medical device quality systems.
- Demonstrated knowledge skills and abilities in integrating human factors through the system engineering lifecycle.
- Demonstrated ability to clearly and accurately translate needs and requirements
- Experience with software and hardware user interface design.
- Experience performing Risk Assessment and trade-off analysis throughout the lifecycle of a product.
- Experience working with physicians and customers in a medical device product development role
- Strong knowledge of regulatory requirements and standards related to human factors engineering in the medical device industry (e.g., FDA, ISO 62366).
- Writing Usability engineering reports for FDA and EU submission.
- Ability to grow productive, trusting, and open relationships with a wide variety of constituencies.
- 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.
- Strong initiative and passion about new technologies with high energy.
Preferred
- Graduate degree in Human Factors Engineering, Usability Engineering, or another relevant scientific discipline.
- Board certification in Human Factors or Professional Ergonomics.
- 5+ years systems engineering experience
- Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical and software
- Voice-of-customer experience and fluency with clinical radiology terminology.
Other
- Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented within the team.
- Ability to travel up to 20% of the time
Required Experience