Sr. Clinical Development Engineer, Endoluminal

Primary Function of Position:

This Sr. Clinical Development Engineer Endoluminal (CDE) position reports to the Sr. Manager of Clinical Development Engineering on the Ion Endoluminal this position a 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.  They also help explore robotic clinical applications for Intuitive products as well as future opportunities to optimize product integration into the clinical setting.

Roles and Responsibilities:

This position has responsibilities include:

• Clinical and Technical Knowledge

  • Apply in-depth knowledge of the clinical procedure and of medical technology in order to become an expert within the company on Intuitives products and clinical applications

  • Collaborate with physicians and key clinical users to understand the clinical need

  • Provide a clinical voice for design and evaluation of Intuitives products

  • Assess potential clinical risks and mitigations to drive appropriate product design

  • In-depth technical understanding of the Intuitive products and adjunct medical device technology that includes mechanical software algorithms electronics aspects of the device

• Product leadership

  • Drive product discovery in collaboration with product management and product design teams by being the internal champion of clinical need

  • Lead early design investigation teams that are lean and efficient for product enhancements & new product ideas

  • Lead post market investigation by conducting clinical risk assessment clinical workflow investigation and pre-clinical testing for critical field issues.

  • Drive stakeholder alignment frequently and solicit appropriate user feedback.

  • Drive decision making and escalate key issues quickly

  • Keep the organizations vision and values at the forefront of decision making and action.

• Design Control Expertise

  • Drive early design decisions with sound understanding of design control clinical risks and evaluation strategy

  • Drive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholders

  • Support product launches and collect early field feedback in collaboration with product management

  • Closely collaborate with other organizations within the company including design marketing regulatory human factors training product management and sales throughout product development and testing

Qualifications :

Skill/Job Requirements:

• B.S. in Mechanical Engineering Biomedical Engineering or similar advanced degree preferred

• Minimum of 6 years of relevant experience in medical device industry required

• Ability to understand complex robotic products

• Experience collaborating with physicians and collecting feedback on clinical use of the product

• Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing regulatory quality product design engineering human factors) to insure project success

• Experienced in driving complex medical devices from concept to market

• Experience developing design validation strategy protocol creation and testing

• Experience leading hands-on product evaluation testing in a pre-clinical lab setting

• Fluent in medical terminology and sound knowledge of anatomy

• Self-starter needing minimal supervision

• Self-confident and able to react quickly under pressure

• Excellent verbal and written communications skills required including presentation of technical content

• 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

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 compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time