Sr. Clinical Development Engineer

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 158,000 - 268,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a Sr. Clinical Development Engineer on the Ion Endoluminal platform.

The role collaborates with physicians and design teams to translate clinical needs into robust product solutions for flexible robotic catheter platforms, with emphasis on design controls and clinical risk assessment. You will participate in early design investigations, drive risk analysis, validation testing, and support clinical trials or launches while aligning with regulatory requirements.

Qualifications

• Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar.
• Minimum 4 years of clinical development and design control experience including the MS.
• Experience driving medical device products from concept to market.
• Experience collaborating with physicians and collecting clinical feedback.
• Experience performing clinical risk analysis.

Responsibilities

• Collaborate with physicians and design teams to define clinical needs and requirements.
• Lead clinical risk analysis and testing for new product features.
• Drive design validation testing strategy with regulatory stakeholders.
• Support product launches and clinical trials with field feedback.

Skills

Clinical development

Design control

Regulatory collaboration

Risk analysis

Clinical workflow

Cross-functional leadership

Education

Master's or PhD in engineering

Job description

Sr. Clinical Development Engineer (Finance)

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Job Description

Primary Function of Position:

This Sr. Clinical Development Engineer (CDE) position reports to the Clinical Development Engineering Manager on the Ion Endoluminal platform. In this position, Sr. CDE utilizes their in-depth clinical, technical and design control knowledge to collaborate with physicians and design engineering to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms. Their primary focus is to understand user needs, establish clinical and engineering requirements, consider clinical risks and identify solutions to guide product development. This position will also allow exploration of future robotic clinical applications and solutions.

Roles and Responsibilities

• Clinical and Technical knowledge
  • Apply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needs
  • Collaborate with physicians and key clinical users on clinical procedure development and understanding product feedback
  • Clearly define clinical need and requirements for product
  • Develop test models and test methods for clinically relevant product evaluations.
  • Assess potential clinical risks and propose mitigations as an input to product design
  • Observe cases and communicate assessment of robotic value and/or opportunities
  • Contribute expertise into clinical protocol design and strategy
• Product Leadership
  • Participate in early design investigation teams that are lean and efficient with a focus on product enhancements & new product ideas.
  • Drive frequent stakeholder alignment and solicit appropriate user feedback
  • Drive decision making and elevate key issues quickly
  • Keep the organization's vision and values at the forefront of decision making and action
  • Educate cross functional team on clinical workflow
  • Support product launches and/or clinical trials and collect early field feedback
• Design Control
  • Conduct clinical risk analysis for new products or updates
  • Lead testing and clinical evaluations of new product features
  • Collaborate with cross functional team members including regulatory, human factors, training, engineering and product management to determine design and development key inputs
  • Drive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholders

Qualifications

Skill/Job Requirements:

• Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar
• Minimum of 4 years of clinical development and design control experience including the MS
• Experienced in driving medical device products and features from concept to market
• Experience collaborating with physicians and collecting feedback on clinical use of the products
• Experience understanding clinical harms and performing clinical risk analysis
• Fluent in medical terminology and sound knowledge of anatomy

Nice to haves:

• Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to ensure project success.
• Experience developing design validation strategy, protocol creation and testing
• Experience leading hands-on product evaluation testing in a pre-clinical lab setting
• Self-starter needing minimal supervision
• Self-confident and able to react quickly under pressure
• Ability to adapt priorities in a fast paced, dynamic, product development team
• Excellent verbal and written communications skills including presentation of technical content

Travel

• Ability to travel up to 25% of the time, internationally and domestic

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 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.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

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.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills.

Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.

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 compensation ranges are listed.

Base Compensation Range Region 1: $186,100 USD - $267,900 USD

Base Compensation Range Region 2: $158,200 USD - $227,700 USD

Shift: Day

Workplace Type: Onsite - This job is fully onsite.