Manager, Clinical Development Engineering

Primary Function of Position:

The Clinical Development Engineering (CDE) Manager leads a team and uses their in-depth knowledge of the Da Vinci Surgical Systems and surgical workflows to work with clinicians and cross-functional partners to develop safe and highly effective MP Platform products. The CDE Manager is responsible for establishing data-driven clinical requirements the validation of new products to ensure high-quality patient outcomes and for conveying clinical value throughout the organization. The team focus will be primary support for System/Software development projects while working in concert with MP technology development partners (including instruments & accessories energy stapling and vision) and MP surgical procedure development partners.  From a management focus the CDE manager will serve as the liaison and lead contact with the MP business unit for the CDE department taking a business-centric view of all MP programs and projects.

Roles and Responsibilities:

Product Development

• Manages clinical development engineering activities and resources related to new product development:
  • Developing clinical product requirements and performance goals
  • Assessing and documenting clinical risks and mitigations and advising engineering regarding risks and mitigations
  • Providing clinical guidance to engineering product design teams
  • Performing informal assessments of the clinical performance of prototype designs
  • Creating and executing formal clinical validations of final product designs
  • Supporting first human use and/or launch of new products
• Understands the clinical needs of surgeon and OR team and monitors the progression of state-of-the-art surgical technique and technologies to help define products that provide clinical value for the patient and are technically feasible.
• Works with cross-functional partners internal SMEs and surgeons and external KOLs to identify the clinical value and potential market opportunity of new Da Vinci MP systems and surgical products.
• Collaborates with cross-functional partners including Engineering Marketing Clinical Affairs Regulatory Affairs Quality and Project Management to develop and launch new products that enhance and support robotic surgery.
• Provides assessment of complex trade-offs challenges and risks with products to the product development team to ensure broad market acceptance of new product designs.
• Contributes to the strategic plan and roadmap for future product development working with internal and external stakeholders.
• Articulates and promotes process improvements that accelerate or strengthen product development processes and results.
• Supports strategic planning and creation of regulatory submissions and first human use of product
• Works with cross-functional user facing teams (HF IxD marketing/sales) to identify and collaborate with key opinion leaders and together provide a unified voice of the customer
• Works with upstream colleagues to identify product enhancements and influence new ideas by leading data driven clinical evaluations and research
• Works with downstream colleagues to support clinical trials for our products and their applications establish best practices and validate marketing claims

Management

• Organization:
  • Keeps the organizations vision values strategy and goals at the forefront of decision making and action
  • Consistently demonstrates culture and values of the organization internally and externally
• Team:
  • Hires trains and develops high performing staff and supports their long-term professional development. Coaches and provides feedback on an ongoing basis
  • Provides vision for the team ensuring successful development of new products and solutions. Fosters an environment that encourages creativity and crisp execution and recognizes achievements contributions and learning
  • Develops methodology and encourages team members to use accurate data and appropriate judgment to form decisions
  • Establishes sub-team objectives and work goals consistent with overall departmental and project goals.
  • Facilitates alignment of priorities reviews metrics and tracks progress
  • Assesses employee performance and provides coaching
  • Influences and builds bridges across CDE and cross-functional teams and throughout the BU to improve communication and processes; keeps team on target and collaborates with functional leadership to resolve conflicts and address needs quickly
• Seeks recognizes and executes creative and simple solutions to resolve complex situations; routinely steadies the team when stressed; leads by example

Qualifications :

Required Skills and Experience

• 8 years of experience in medical device product development (surgical devices preferred) and 1-3 years of management responsibilities through technical leadership project management or people leader role
• A leader who is a consistent high performer a continual learner and leads with emotional intelligence
• A team player
• Self-starter with ability to take leadership in a fast-paced and dynamic environment
• Experience interacting with surgeons and their teams in an operating room environment with recognized clinical credibility and surgical acumen. Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
• Aptitude to cultivate collaboration with Key Opinion Leaders and influence cross-functional teams without formal authority to ensure project success
• Proven success in recognizing critical issues with the ability to react quickly under pressure and driving issues to closure by providing coordinated direction. Creative in succeeding
• Strong project management planning decision making negotiating and change management skills
• Excellent communication skills (verbal written presentation) and experience conveying complex ideas to others

Required Education and Training

• Minimum Bachelor of Science degree required in Engineering or equivalent

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  

• Current or previous experience as an Intuitive Clinical Development Engineer preferred
• Experience in managing direct reports is a plus
• OR/Scrub experience cadaveric and animal surgical experience a plus

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 employeeswho 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 governments 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 employeesstart 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.

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