Staff Engineer, Design Validation

What You Will Do

• 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.

What You Need (Required Qualifications)

• 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.

Preferred Qualifications:

• 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.