Job Description

The Sr. Manager Clinical Research Engineering uses their in-depth clinical, scientific, and technical knowledge to lead, collaborate with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop new product concepts being incubated in early exploration. The individual brings their clinical device development expertise to new platform and technology development, and is responsible for identifying, documenting, and understanding user needs and subsequently communicating these needs to inform concept design and development.

Responsibilities

Advanced research lead and new product concept development

• Leads research on disease states and medical technologies associated with new business opportunities for Intuitive and applying their in-depth knowledge to become an expert within the company on the new products being developed and their clinical application.
• Key stakeholder, collaborates closely with engineers and physicians to define clinical performance goals and potential risks for new products in early phase pf 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.
• Monitors and advices complex technical and clinical aspects of the product.
• Hire, develop and mentor 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.
• Collaborate 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.
• Develop and execute clinical de-risking pathways including both pre-clinical and clinical feasibility studies.
• Contribute to market development and segmentation for new clinical applications.

Clinical innovation

• Develop novel clinical models and metrics for technology evaluation and prototype performance assessment.
• Develop novel procedures and workflows for new technologies.
• Design, develop, and execute clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration.
• Conduct design iteration assessments of products both internally and with external key opinion leaders.
• Identify and drive product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users.
• Develop and execute a preclinical evaluation strategy in advance of human trials and for regulatory submissions.
• Lead and execute early-stage feasibility, pilot, and pivotal studies to support technology development for regulatory and reimbursement strategies.
• Develop intellectual property for novel clinical applications and technologies.
• Keep the organization's vision and values at the forefront of decision making and action.
• Perform other duties as required to support the company's overall strategy and goals.

Qualifications

Qualifications

Required Education, Skills & Experience

• 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.

Preferred Skills & Experience

• Experience working in an operating room.
• Experience collaborating with physicians and collecting feedback on clinical use of the product.
• Experience with on-site clinical trial support.

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.

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.