Primary Function of the Position
The Senior Digital Clinical Development Engineer (CDE) uses their in-depth knowledge of the surgical environment and medical technology to work with design engineers and clinicians to define, develop, and validate the clinical function of new digital products within our multi-port and single-port surgical robotic platforms. The primary focus of the CDE is to establish and validate data-driven clinical and user-facing requirements to ensure a high-quality patient outcome.
Essential Job Duties
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Apply in-depth knowledge of the operating room environment and of the da Vinci Surgical Systems to become an expert within the company on the clinical application of Intuitive’s products
- Provide a clinical voice to product development by defining and assessing clinical performance of new products
- Collaborate with marketing partners and clinicians to identify and understand clinical needs
- Use an analytical approach to identify potential product enhancements and new product ideas
- Take an active role in new product development teams, including contributing to design reviews, and providing design guidance to engineering design teams
- Assess and document clinical risks, and identify appropriate mitigations
- Conduct pre-clinical testing to validate the safety and efficacy of new products
- Support regulatory documentation and submissions
- Provide subject matter expertise to user manual and training documentation development
- Support clinical evaluation of new products at key customer sites
- Maintain current knowledge of clinical applications of Intuitive’s products
- Keep Intuitive’s vision and values at the forefront of decision making
- Perform other duties as required to support the company’s overall strategy and goals
- Assist in the preparation of regulatory submissions, such as 510(k)s or IDEs, ensuring compliance with relevant regulatory requirements.
Required Skills and Experience
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Minimum of 8 years of experience in medical device industry with a Bachelor’s degree, 6 years experience with a Master’s degree, or 3 years with a PhD degree
- Experience working with surgeons in an operating room environment
- Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
- Excellent mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products
- Excellent analytical capability and practical skills to develop test methods and draw conclusions
- Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines
- Effective communication skills (verbal, written, presentation)
- Proven success recognizing critical issues and driving them to closure by taking coordinated action
- Self-starter needing minimal supervision
- Self-confident and able to react quickly under pressure
Required Education and Training
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Minimum of Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, Software Engineering, or similar; advanced degree preferred
Working Conditions
- Ability to travel up to 25% of the time, international and domestic
- Ability to see all colors, have stereoscopic vision, and have near and far visual acuity (clarity between 12 inches and 20 feet with or without corrective lenses).
- Ability to work standing for several hours in an OR environment
Preferred Skills and Experience
- 5+ years experience in software development or clinical engineering, with a focus on medical devices or healthcare applications.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
EEO and AA Policy
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
