Compensation Overview

CORE RESPONSIBILITIES

• Develop and apply in-depth technical and clinical knowledge in urological anatomy, disease states, procedures, and associated products.
• Evaluate clinical publications and data to provide insights to inform product strategy and development.
• Partner with Product Managers to clearly define clinical needs and product requirements.
• Collaborate with cross-functional teams including engineering, regulatory, quality, and clinical affairs, providing clinical guidance and support throughout the product development process, such as clinical risks and potential mitigations.
• Develop and maintain relationships with key opinion leaders (KOLs), surgeons, and clinical stakeholders to gather feedback and validate product concepts.
• Lead testing and clinical evaluations or new product concepts and features.
• Drive and execute design and clinical validation strategies for new products, gaining alignment from key stakeholders.
• Drive continuous improvement initiatives to enhance product performance, usability, and clinical outcomes based on firsthand case observations, post-market feedback and real-world experience.
• Assist in the development of plans, reports, and other materials to support engagements with the FDA and other regulatory bodies.
• Develop training materials, clinical documentation, and educational resources for internal teams, customers, and users, in partnership with Downstream Marketing and the Global Learning Department.
• Support initial product launches by supporting initial cases during LMR (Limited Market Release)
• Support development and commercial efforts by participating in conferences, symposiums, and customer engagements to showcase product capabilities and clinical evidence.
• Stay abreast of regulatory requirements, standards, and guidelines related to medical devices and surgical robotics to ensure compliance and mitigate risks.

QUALIFICATIONS (Education, Experience, Certifications)

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
• Minimum B.S. in Biomedical Engineering, or a similar discipline.
• Minimum 7 years of experience of clinical development engineering and/or product management in the medical device industry, min of 5 years with an advanced degree.
• Experience driving products and features from concept to launch.
• Demonstrated ability to build strong working relationships with surgeons, surgical staff and internalemployees.
• Experience understanding clinical harms and performing clinical risk analysis.
• Knowledge of human anatomy, surgical terminology, and surgical techniques.
• Experience working with surgeons and staff in the operating room
• Professional work ethic, high capacity, strong analytical and organizational skills, and ability to operate independently.
• Track record of executing complex medical device product development; experience with capital equipment preferred.
• Excellent communication skills and attention to detail
• Experience working with cross-functional teams.
• Strong multi-tasking skills with an ability to adapt to change.
• Ability to travel up to 30% of thetime.
• Computer skills: Microsoft Word, Excel, PowerPoint required, Jama and Jira experience preferred.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 40 pounds. 
• While performing the duties of this job, the employee commonly works in an office environment, specimen labs, and the operating room.