Senior Clinical Development Engineer- SP, I&A
HybridSunnyvale, California, United States
Job Summary
Define and validate clinical requirements for new products within the Single-port surgical robotic platform by collaborating with design engineers and clinicians. Assess clinical performance, identify potential enhancements, and conduct pre-clinical testing to validate safety and efficacy. Collaborate with marketing partners to understand clinical needs, assess and document clinical risks with appropriate mitigations, and support regulatory documentation submissions. Contribute to design reviews, provide subject matter expertise for user manual development, and support clinical evaluations at key customer sites. Maintain current knowledge of clinical applications and assist in defining and assessing clinical performance of new products.
Required Qualifications
- 8 years of experience in medical device industry with a Bachelor's degree
- 6 years experience with a Master's degree
- 3 years with a PhD degree
- Proven experience in supporting a medical product from design to launch
- 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
- Ability to travel up to 25% of the time, internationally and domestic
- For positions related to development of the optical/vision system, the ability to have near and far visual acuity (clarity between 12 inches and 20 feet with or without corrective lenses), stereoscopy, and the ability to see all colors
Desired Qualifications
- 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
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