Senior Clinical Research Engineer

Intuitive•Sunnyvale, CA

5d•$186,100 - $267,900•Onsite

About The Position

The Senior Clinical Research Engineer uses 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 applies clinical device development expertise to new platforms and technologies, identifies and documents user needs, and communicates those needs to inform concept design and development. The position also includes hiring, developing, and mentoring a small group of Clinical Research Engineers.

Requirements

M.S. 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 within 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.
Strong mechanical and technical aptitude and spatial reasoning, including the ability to understand complex mechanical products.
Strong analytical capabilities and practical skills to develop and test clinical hypotheses and draw concise conclusions.
Strong teamwork skills and ability to foster collaboration across disciplines.
Proven ability to recognize critical issues and drive them to resolution through coordinated action.
Effective verbal, written, and presentation communication skills.
Ability to work independently with minimal supervision.
Interest in expanding into people management.

Nice To Haves

Medical robotics experience.
Experience with clinical procedures for minimally invasive general surgery, spine surgery, orthopedics, and adjacent procedures.
Experience with visualization, ultrasound guidance, energy instrumentation, medical surgical instrumentation, and pretreatment MRI and CT planning.
Operating room experience.
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.
Architect clinical requirements, clinical risks, and mitigations.
Research disease states and medical technologies relevant to new business opportunities, and develop expertise in the 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 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.
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, and translate feedback for engineering teams.
Assess product design iterations internally and with external key opinion leaders.
Identify and drive product enhancements and new product ideas by analyzing clinical needs.
Develop and execute preclinical evaluation strategies ahead of human trials and for regulatory submissions.
Perform other duties required to support the company's strategy and goals.