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Sr. Clinical Development Engineer Advanced Development

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of the Position

The Senior 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 products within our multi-port robotic platforms. The primary focus of the CDE is to establish and validate data-driven clinical requirements to ensure a high-quality patient outcome. This role supports Multiport Systems Advanced Development.

Essential Job Duties

  • ​​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 a data-based approach to identify potential product enhancements and new product ideas
  • ​Take a dynamic 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

Qualifications

Required Skills and Experience

  • 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
  • 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 data-backed 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
  • ​Poised and able to react quickly under pressure

Required Education and Training

  • ​​Minimum of Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or similar; advanced degree preferred

Working Conditions

  • 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 is required.

Preferred Skills and Experience

  • None

Additional Information

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 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.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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.

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. 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.

Mandatory Notices

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.

Average salary estimate

$125000 / YEARLY (est.)
min
max
$100000K
$150000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Sr. Clinical Development Engineer Advanced Development, Intuitive

At Intuitive, we're on a mission to enhance patient care through minimally invasive techniques, and we're looking for a Senior Clinical Development Engineer for our Advanced Development team in Sunnyvale, CA. This role calls for someone with a profound understanding of the clinical landscape and medical technology, working hand-in-hand with design engineers and surgeons to shape the future of robotic-assisted surgery. As a Senior Clinical Development Engineer, you'll focus on defining and validating clinical requirements that directly impact patient outcomes. Your clinical expertise will guide product development, helping to identify and solve real-world challenges faced in the operating room. You'll engage with cross-functional teams, contribute to design reviews, and utilize a data-driven approach to enhance our innovative robotic platforms. You'll work closely with marketing partners and clinicians to ensure that our products not only meet but exceed the needs of healthcare professionals. In this collaborative environment, your insights will be crucial in assessing clinical risks and guiding essential mitigations. Beyond developing cutting-edge technologies, you will also conduct pre-clinical testing, contribute to regulatory documentation, and uphold our commitment to high-quality patient care. At Intuitive, we foster a culture of inclusion and respect, encouraging our engineers to bring their authentic selves to work. Join us, and let's ambitiously push the boundaries of what's possible for minimally invasive care together.

Frequently Asked Questions (FAQs) for Sr. Clinical Development Engineer Advanced Development Role at Intuitive
What are the responsibilities of a Senior Clinical Development Engineer at Intuitive?

As a Senior Clinical Development Engineer at Intuitive, your primary responsibilities include collaborating with design engineers and clinicians to define and validate clinical requirements for our robotic platforms, conducting pre-clinical testing, and supporting regulatory submissions. You'll also play a crucial role in assessing clinical risks and documenting appropriate mitigations to enhance product safety and efficacy.

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What qualifications are required for the Senior Clinical Development Engineer position at Intuitive?

To qualify for the Senior Clinical Development Engineer position at Intuitive, you should have a minimum of 8 years of experience in the medical device industry, ideally with a relevant Bachelor’s degree. Additionally, experience working in a surgical environment and with surgical terminology is crucial. Those with a Master's degree should have at least 6 years of experience, while candidates with a PhD should have a minimum of 3 years in the field.

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How does Intuitive support the growth and development of Senior Clinical Development Engineers?

Intuitive is dedicated to the long-term growth of its team members, particularly Senior Clinical Development Engineers. The company invests in ongoing training and professional development, fostering a culture where engineers can expand their knowledge and skill sets, ultimately enabling them to take on new challenges and advance in their careers.

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What kind of experience is needed in the operating room for the Senior Clinical Development Engineer at Intuitive?

Experience in the operating room is essential for the Senior Clinical Development Engineer role at Intuitive. Candidates should have a strong familiarity with surgical terminology and techniques, as well as hands-on experience working alongside surgeons. This knowledge empowers engineers to effectively contribute to product development that meets the unique challenges faced in surgical settings.

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What opportunities for collaboration exist for a Senior Clinical Development Engineer at Intuitive?

As a Senior Clinical Development Engineer at Intuitive, you will have abundant opportunities for collaboration, working closely with design engineers, clinicians, marketing partners, and cross-functional teams. This collaborative approach ensures that diverse perspectives are integrated into product development, ultimately leading to innovative solutions that enhance patient care.

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Common Interview Questions for Sr. Clinical Development Engineer Advanced Development
Can you describe your experience in the medical device industry relevant to the Senior Clinical Development Engineer role?

When discussing your experience in the medical device industry, be specific about the projects you've worked on and the outcomes achieved. Highlight your roles in product development from design to launch, especially emphasizing any relevant surgical insights and collaborations with clinicians to better frame your qualifications.

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How do you ensure that your clinical requirements align with the needs of end-users?

To address this question, share your approach to gathering user feedback, involving clinicians early in the design process, and leveraging data analytics to guide your clinical requirements. Discuss specific methods you've utilized to maintain constant communication with stakeholders, ensuring that end-user needs are prioritized.

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Tell us about a time when you identified a critical issue during product development.

In response to this question, provide a concrete example that showcases your problem-solving skills. Detail the methods you employed to identify the issue, the actions you took to resolve it, and the final outcome. This demonstrates your capacity for critical thinking and your ability to drive solutions in high-pressure situations.

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What strategies do you use to communicate complex technical information to non-technical stakeholders?

When answering this question, emphasize the importance of clarity and conciseness. Describe how you tailor your presentations or discussions to the audience’s level of understanding, using visual aids, analogies, and straightforward language to assure all parties grasp the essential concepts.

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Describe your experience working with surgeons or in surgical environments.

Share specific experiences collaborating with surgeons, including how you developed a rapport with them and how their input influenced product design. Highlight scenarios where your understanding of surgical environments enabled you to address their needs effectively.

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How do you stay updated on advancements in medical technology?

Discuss your commitment to continuous learning by sharing examples of professional development courses, conferences, journals, or online platforms you engage with. Explain how staying informed allows you to bring innovative ideas and insights into your role as a Senior Clinical Development Engineer.

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What role do you think data plays in defining clinical performance?

Emphasize that data is crucial for making informed decisions in clinical performance assessment. Discuss your experience with collecting and analyzing data to validate clinical requirements, and how such an approach can lead to improvements in product design and patient outcomes.

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How do you handle tight deadlines and pressure in the development process?

Describe your time management strategies and your ability to prioritize tasks effectively. Sharing an example of a past experience can illustrate your resilience and problem-solving skills. Highlight how you maintain focus and keep the team motivated during intense project phases.

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Can you discuss a successful project you've led in the past?

When discussing a past project, outline the objective, your role, the steps you took to lead the project, and the results achieved. Include metrics or outcomes that demonstrate the project's success to provide concrete evidence of your capabilities.

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What is your approach to regulatory documentation and compliance?

Discuss your familiarity with regulatory requirements in the medical device industry. Detail your experience in preparing necessary documentation and ensuring compliance through effective project management and attention to detail. Illustrate with examples of successful submissions or audits you've navigated.

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Founded in 1995, Intuitive Surgical, Inc develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The company is headquartered in Sunnyvale,...

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March 21, 2025

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