Lead Clinical Development Engineer-Medical Device Innovator

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 228,000 - 279,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA seeks a Principal Clinical Development Engineer to lead translational research and clinical development for dV Cardiac products. You will initiate and oversee design, development, execution of studies, and collaborate with CDE, product teams, and clinicians to create knowledge that guides high-quality patient outcomes.

The role emphasizes operating room expertise, collaboration with surgeons, risk documentation, regulatory submissions, and IP filings.

Qualifications

• 15+ years of experience in medical device industry with a Bachelor’s degree, 12 years experience with a Master’s degree, or 8 years with a PhD degree; or equivalent experience
• Experience working with surgeons in an operating room environment; Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
• Experience working in preclinical labs and with cadaveric or animal models; Strong ability to design and execute clinical or preclinical evaluations and translate results into development direction
• Excellent communication skills, including the ability to clearly convey complex ideas across clinical and technical audiences

Responsibilities

• Define and drive key research projects with the goal of contributing to the development of new products or improvement of existing ones.
• With an understanding of complex product designs and component interactions, specify devices, materials selections, and design features to effectively implement new concepts and technologies
• Support product development teams by providing technical expertise during problem solving and brainstorming exercises
• Develop, drive and contribute to intellectual property filings for novel clinical applications and technologies
• Collaborate with cross-functional stakeholders and use knowledge to influence project strategy, foresee project risks and future-proof project deliverables
• 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
• Work with key opinion leaders, subject matter experts, physicians, and other stakeholders to identify clinical goals and translate those needs for user-centric design and development of new platforms, procedures, instruments, and/or accessories
• Support clinical risk documentation, pre-clinical test strategy and execution, and regulatory submissions for new products
• Work through difficult and unique problems. Achieve sound results within challenging constraints. Influence teams on high-impact project decision making
• Drive complex projects by supporting key decisions across multiple areas of expertise with strategic stakeholders. Make clinical decisions, set priorities and assess validity of others' approaches.
• Positively collaborate at all levels of the organization. Able to confidently provide responses when questioned on topics relevant to scope of work in ways that generate understanding and confidence.
• Strong sense of shared responsibility and shared reward /success with peers from all teams
• May supervise or mentor other team members.
• 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

Skills

Medical device experience

Clinical development

Operating room exposure

Project leadership

Clear communication

Education

Bachelor's degree

Master's degree

PhD degree

Job description

Intuitive Surgical in Sunnyvale, CA seeks a Principal Clinical Development Engineer to lead translational research and clinical development for dV Cardiac products. You will initiate and oversee design, development, execution of studies, and collaborate with CDE, product teams, and clinicians to create knowledge that guides high-quality patient outcomes.

The role emphasizes operating room expertise, collaboration with surgeons, risk documentation, regulatory submissions, and IP filings.