Sr. Clinical Development Engineer, MP Instruments (2 openings)

Intuitive; Sunnyvale (CA); On-site; USD 186,100 - 267,900; Full time

Job summary

Intuitive is seeking a Sr. Clinical Development Engineer in Sunnyvale, CA. This position focuses on defining clinical requirements for new products in multi-port robotic platforms and requires extensive experience in the medical device industry.

The ideal candidate must have a Bachelor’s degree in Mechanical or Biomedical Engineering, and will collaborate with design engineers to ensure high-quality patient outcomes. Responsibilities include supporting clinical evaluations and collaborating with surgeons.

Qualifications

• Minimum of 8 years in medical devices with a Bachelor’s degree.
• Experience supporting a medical product from design to launch.
• Experience in an operating room with surgeons.

Responsibilities

• Define and assess clinical performance of new products.
• Conduct pre-clinical testing for product safety.
• Support regulatory documentation and submissions.

Skills

Experience in medical device industry

Surgical terminology

Mechanical aptitude

Analytical capability

Teamwork skills

Ability to react under pressure

Education

Bachelor of Science degree in Mechanical Engineering or Biomedical Engineering

Job description

Sr. Clinical Development Engineer, MP Instruments (2 openings)

• Full-time
• Shift: Day
• Max. Salary Region 2: 227700 USD
• Max. Salary Region 1: 267900 USD
• Ways of Working: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
• Employee Type: Employee
• Min. Salary Region 1: 186100 USD
• Global Job Level (HCM): Professional 4 (11)
• Min. Salary Region 2: 158200 USD

Primary Function of the Position

The Sr. Clinical Development Engineer, Multiport Instruments (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.

Responsibilities

• 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

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 analytical capability and practical skills to develop test methods and draw conclusions
• Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines
• Proven success recognizing critical issues and driving them to closure by taking coordinated action
• Self-confident 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.

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.

Equal Opportunity Employer

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.

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 obtain an export license from the U.S. Government on your behalf. For any 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.

Fair Chance and Geographic Preference

• 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.

Location and Compensation

Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity, are offered. It would not be typical for someone to be hired at the top end of the 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 above.