Sr. Clinical Engineer

Intuitive; Sunnyvale (CA); On-site; USD 125,000 - 150,000; Full time

Job summary

An established industry player is seeking a Sr. Clinical Engineer to drive innovative product concepts in medical technology. This role involves collaborating with engineers and physicians to assess clinical needs, develop new product strategies, and execute clinical evaluations. The ideal candidate will leverage their expertise to enhance product performance and safety, while contributing to market development and regulatory strategies. Join a forward-thinking team dedicated to advancing healthcare solutions and making a significant impact in the field of clinical engineering. This is an exciting opportunity for those passionate about innovation and collaboration in a dynamic environment.

Qualifications

• In-depth knowledge in clinical engineering and product development.
• Experience in conducting clinical evaluations and feasibility studies.

Responsibilities

• Collaborate with engineers and physicians to define clinical performance goals.
• Develop and execute clinical derisking pathways and evaluations.

Skills

Clinical Engineering

Product Development

Clinical Research

User Experience Research

Risk Assessment

Collaboration

Data Analysis

Education

Bachelor's Degree in Engineering or related field

Advanced degree (Master's or PhD) in Clinical Engineering or related field

Tools

Clinical Evaluation Metrics

Prototype Assessment Tools

Job description

Job Description

Primary Function of the Position

The Sr. Clinical Engineer uses their in-depth clinical, scientific, and technical knowledge to collaborate with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop new product concepts being incubated in early exploration. The person 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. The Sr. Clinical Engineer is responsible for developing and executing an experimental strategy to assess performance and safety of prototype designs, and is a key contributor in the design and development iteration process. The team member will take a dynamic role in the concept design team by assessing and communicating clinical risks, providing design guidance, inventing new concepts and executing the overall clinical strategy. The Sr. Clinical Engineer also partners closely with team members such regulatory, clinical affairs, finance, and more to develop the clinical indication and commercialization strategy.

Essential Job Duties

The Sr. Clinical Engineer will:

Advanced research and new product concept development

• Research disease states and medical technologies associated with new business opportunities for Intuitive, and applying their in-depth knowledge in order to become experienced within the company on the new products being developed and their clinical application
• Collaborate closely with engineers and physicians to define clinical performance goals and potential risks for new products in early-phase development
• Work with 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, etc.
• Develop and execute clinical derisking 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 a data-based 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
• Manage and execute early stage feasibility studies, pilots, and pivotals to support technology development for regulatory and reimbursement strategies
• Develop intellectual property for novel clinical applications and technologies

Other

• 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