Sr. Clinical Development Engineer -- Software and Systems

Company Description

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:

The responsibilities for this position include:

• Clinical and Technical knowledge

1. Apply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needs
2. Collaborate with physicians and key clinical users on clinical procedure development and understanding product feedback
3. Clearly define clinical need and requirements for product
4. Develop test models and test methods for clinically relevant product evaluations
5. Assess potential clinical risks and propose mitigations as an input to product design
6. Evaluate and assess clinical impact resulting from SW algorithm updates
7. Support post market investigation by driving clinical risk assessment, clinical workflow investigation and pre-clinical testing for critical field issues

• Product Lead

1. Drive product discovery in collaboration with product management and product design teams by being the internal champion of clinical need.
2. Participate in early design investigation teams that are lean and efficient with a focus on product enhancements & new product ideas
3. Drive frequent stakeholder alignment and solicit appropriate user feedback
4. Drive decision making and escalate key issues quickly
5. Keep the organization’s vision and values at the forefront of decision making and action
6. Create Best Practices guidelines, white papers
7. Educate cross functional team on clinical workflow

• Design Control

1. Support design control deliverables for new product and changes
2. Conduct clinical risk analysis for new product updates
3. Lead testing and clinical evaluations of new product features
4. Collaborate with cross functional team members including regulatory, human factors, training, engineering and product management to determine design and development key inputs
5. Drive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholders
6. Support product launches and collect early field feedback in collaboration with product management

Qualifications

Skill/Job Requirements:

• Minimum Masters or PhD in Controls Engineering, Computer Science, Biomedical Engineering or similar
• Minimum of 6 years of clinical development and design control experience
• Experienced in driving software-based product and features from concept to market
• Ability to understand software algorithms in-depth
• 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
• Experience understanding clinical harms and performing clinical risk analysis
• 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
• Ability to adapt priorities in a fast paced, dynamic, product development team
• Excellent verbal and written communications skills 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 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.

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.

Base Salary Range Region 1: $161,500 - $232,500
Base Salary Range Region 2: $137,400 - $197,700
Shift: Day
Travel: 25% of the time
Workplace Type: Onsite - This job is fully onsite.