Staff Engineer, Design Validation

What You Will Do:

• Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies.
• Lead various design validation activities including preparing stimulated use environments, defining sample size and acceptance criteria, managing participant recruitment for Digital, Robotics and Enabling Tech products.
• Develop and validate all clinically relevant use cases for navigated and robotic orthopedic procedures by engaging with KOLs, observing clinical procedures, etc.
• Apply in-depth knowledge of the operating room environment and complex medical technology to perform clinically relevant design validation testing.
• Participate in various user-centric development activities and confirm user needs are met effectively in all aspects of device design, packaging, labeling and training.
• Use strong Systems Engineering Principles to drive best practices in User Needs, Requirements, and V&V activities.
• Collaborate with various cross-functional teams such as Medical Education and Marketing to mimic field-training in support of successful medical device launch.
• Ensure all design validation activities are conducted in accordance with relevant regulations and standards, and industry’s best practices.

What You Will 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
• 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 User Needs Research, Design validation, and med tech product development.
• Excellent problem-solving, analytical and communication skills.
• Strong collaborative and leadership skills, with the ability to work effectively with cross-functional teams.