Senior Clinical Research Engineer

Intuitive•Sunnyvale, CA

About The Position

The Senior Clinical Research Engineer (Sr CRE) applies in-depth clinical, scientific, and technical knowledge to lead and collaborate with engineers, physicians, user experience researchers, and other stakeholders on new product concepts in early exploration. The role contributes clinical device development expertise to new platform and technology development and identifies, documents, and communicates user needs to inform concept design and development. The description also notes that the Managing CRE is a technical individual with an aptitude and desire to expand into people management. The role leads advanced research and new product concept development, including identifying clinical needs, defining clinical requirements and risks, researching disease states and medical technologies, and establishing clinical performance goals. It works across engineering, regulatory, human factors, industrial design, training, marketing, and other organizations to guide the clinical aspects of new programs and platform development. The position develops clinical de-risking pathways and preclinical and clinical feasibility studies, and develops and executes clinical evaluations of prototypes, translating feedback into engineering improvements. The Senior Clinical Research Engineer also develops clinical models, metrics, procedures, and workflows for evaluating new technologies; assesses design iterations with internal teams and external key opinion leaders; and drives product enhancements and new product ideas based on clinical needs. The role may hire, develop, and mentor a small group of CREs and performs other duties supporting the company’s strategy and goals.

Requirements

Master’s degree or Ph.D. in Biomedical Engineering, Mechanical Engineering, or a similar field.
At least 5 years of related experience in clinical engineering and/or product development in the medical device industry.
Experience with product development and Design Controls.
Fluency in medical procedure terminology and sound knowledge of anatomy.
Ability to understand complex robotic systems and software algorithms.
Excellent mechanical and technical aptitude, including spatial reasoning and the ability to understand complex mechanical products.
Strong analytical capability and practical skills to develop and test clinical hypotheses and draw concise conclusions.
Strong teamwork skills and demonstrated ability to foster collaboration across disciplines to support timely project success.
Demonstrated ability to recognize critical issues and drive them to closure through coordinated action.
Effective verbal, written, and presentation communication skills.
Self-starter who requires minimal supervision.
Interest in expanding into people management.

Nice To Haves

Medical robotics experience.
Experience with clinical procedures in minimally invasive general surgery, spine surgery, orthopedics, or adjacent procedures.
Experience with visualization, ultrasound guidance, energy instrumentation, medical-surgical instrumentation, or pretreatment MRI and CT planning.
Experience working in an operating room.
Experience collaborating with physicians and collecting feedback on clinical product use.
Experience providing on-site clinical trial support.

Responsibilities

Lead advanced research and new product concept development.
Identify key clinical needs for novel instrumentation, systems, and devices.
Develop clinical requirements and identify clinical risks and mitigations.
Research disease states and medical technologies related to new business opportunities, and develop expertise in new products and their clinical applications.
Collaborate with engineers and physicians to define clinical performance goals and potential risks for products in early development.
Manage, collect, and interpret voice-of-customer feedback across various levels of management.
Monitor and advise on complex technical and clinical aspects of products.
Hire, develop, and mentor a small group of Clinical Research Engineers for the program.
Lead clinical aspects of new programs and platform development in collaboration with design engineering, regulatory, human factors, industrial design, training, marketing, and other organizations.
Develop and execute clinical de-risking pathways, including preclinical and clinical feasibility studies.
Develop clinical models and metrics for technology evaluation and prototype performance assessment.
Develop procedures and workflows for new technologies.
Design, develop, and execute clinical evaluations of prototypes, translating feedback for engineering teams to accelerate technology development.
Assess product design iterations internally and with external key opinion leaders.
Identify and drive product enhancements and new product ideas through analytical assessment of clinical needs.
Develop and execute a preclinical evaluation strategy in advance of human trials and for regulatory submissions.
Perform other duties as required to support the company's overall strategy and goals.