Lead design validation activities including preparing stimulated use environments, participant recruitment, defining sample sizes and acceptance criteria for successful execution of clinical, customer-centric labs.
Collaborate with cross-functional teams to develop high quality user needs and product requirements based on Regulatory strategy, Marketing inputs and applicable standards.
Participate in various Usability and Human Factors activities to refine User Needs and validate all aspects of device design, packaging, labeling and training.
Determine appropriate Design validation methods that are statistically significant, objective and clinically relevant for testing the Intended Use of the product and User Needs.
Develop technical expertise in complex navigation and robotics-assisted orthopedic systems and apply in-depth knowledge of the operating room environment to inform test method development, data interpretation and evaluate product performance and risk.
Use strong Systems Engineering principles and FDA Design Controls knowledge to drive best practices in User Needs, Requirements and V&V activities.
Ensure all design validation activities are conducted in accordance with relevant regulations and standards, and industry’s best practices.

Bachelor’s degree in Biomedical Engineering, Electronic/Electrical Engineering, Human Factors Engineering, or Lifesciences discipline
4+ years of industry experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations.
Experience within the medical device industry
Strong understanding of relevant medical device regulations and standards such as FDA Guidance documents, IEC 62366, 60601-1-6, HE75
Experience in Customer-centric Design, User Needs Research, Accuracy Testing and working through different stages of med tech development.
Background in Navigation, Robotic and complex software-based medical technologies.
Strong collaborative and leadership skills, with the ability to work effectively with cross-functional teams.

Staff Engineer, Design Validation

Key skills