Sr. Manager Clinical Research Engineering

About the role

The Sr. Manager Clinical Research Engineering leads the development of new product concepts in early exploration stages. They collaborate with engineers, physicians, user experience researchers, and other stakeholders to define clinical performance goals and potential risks for new products. They manage and propose budgets, set overall program goals, and align with executive leadership. They also hire, develop, and mentor CREs for the program.

Responsibilities

• Advanced research lead and new product concept development
• Leads research on disease states and medical technologies associated with new business opportunities
• Collaborates closely with engineers and physicians to define clinical performance goals and potential risks for new products in early phase of development
• Manages, collects, and decipher VOC across various levels of management
• Creates plans for 3-year timeframes for clinically complex programs
• Manages and proposes budget, sets overall program goals and aligns with executive leadership
• Makes recommendations for complex technical and clinical aspects of the product
• Hires, develops, and mentors CREs for the program
• Presents findings to key opinion leaders, subject matter experts, physicians, and other stakeholders to identify clinical goals and translate those needs for user-centric design and development of new platforms, procedures, instruments, and accessories
• Collaborates with other organizations within the company as needed leading the clinical aspects of new programs and platform development: design engineering, regulatory, human factors, industrial design, training, marketing, and others
• Develops and executes clinical de-risking pathways including both pre-clinical and clinical feasibility studies
• Contributes to market development and segmentation for new clinical applications
• Clinical innovation
• Develops novel clinical models and metrics for technology evaluation and prototype performance assessment
• Designs, develops, and executes clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration
• Identifies and drives product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users
• Develops and executes a preclinical evaluation strategy in advance of human trials and for regulatory and reimbursement strategies
• Contributes to the development and execution of early-stage feasibility, pilot, and pivotal studies to support technology development for regulatory and reimbursement strategies
• Develops intellectual property for novel clinical applications and technologies
• Performs other duties as required to support the company's overall strategy and goals

Qualifications

• Minimum of a M.S. or PhD in Biomedical Engineering, Mechanical Engineering, or similar field with minimum 1-2 years of leadership experience
• 8+ years of related experience in clinical engineering and/or product development within the medical device industry
• Product development and Design Controls experience
• Fluent in medical procedure terminology and sound knowledge of anatomy
• Ability to understand complex robotic systems and software algorithms
• Excellent mechanical and technical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products
• Excellent analytical capability and practical skills to develop and test a clinical hypothesis and draw succinct conclusions
• Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to ensure timely project success
• Proven success recognizing critical issues and driving them to closure by taking coordinated action
• Familiar with intellectual property development and patent assessment
• Effective communication skills (verbal, written, presentation)
• Self-starter needing minimal supervision

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 Salary Range Region 1:$227,000 - $340,400 Base Salary Range Region 2: $193,000 - $289,300 Shift: Day Workplace Type: Onsite - This job is fully onsite.