Sr. Clinical Research Engineer

Intuitive•Sunnyvale, CA

7h•Onsite

About The Position

The Senior Clinical Research Engineer, Future Forward, leads the design and development of product concepts before commercial launch, applying clinical, scientific, and technical expertise. The role collaborates with engineers, physicians, interaction designers, human factors specialists, training and technical publication specialists, and other internal and external stakeholders to guide product and procedure development. It supports early-stage feasibility studies, gathers clinical insights, identifies and documents user needs, manages product requirements and clinical risks, and provides design guidance for clinical and commercial development. The position develops and executes pre-clinical strategies to assess device performance, safety, and usability throughout the Product Development Process and helps prepare technologies for commercial launch. In collaboration with regulatory, quality, clinical affairs, finance, and other teams, the role contributes to clinical indications and commercialization strategies, advancing technologies from concept to commercial readiness. The position also researches disease states and related medical technologies, works with clinicians and marketing partners to understand needs, and translates clinical goals into user-centric designs for platforms, procedures, instruments, and accessories. It leads or executes feasibility studies and clinical trials, assesses prototype designs, develops pre-clinical evaluation strategies, supports regulatory submissions and user documentation, and analyzes study feedback to inform product requirements, training, and technology improvements. The role may develop intellectual property for novel clinical applications and technologies. The role is based in Sunnyvale, California. The employee must be available to work full-time and commute or relocate to Sunnyvale. Travel is up to 30%, including some international travel.

Requirements

Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or a similar field.
At least 8 years of related experience in clinical engineering and/or product development within the medical device industry.
Fluency in medical procedure terminology and sound knowledge of anatomy.
Ability to understand complex robotic systems and software algorithms.
Experience working in an operating room or interventional suite environment.
Experience collaborating with physicians and collecting feedback on clinical product use.
Excellent mechanical and technical aptitude and spatial-relation intuition, including the ability to understand complex mechanical products.
Strong analytical capability and practical skills to develop and test clinical hypotheses and draw succinct conclusions.
Excellent teamwork skills and a proven ability to foster collaboration across disciplines to support timely project success.
Proven ability to recognize critical issues and drive them to closure through coordinated action.
Product development and Design Controls experience.
Effective verbal, written, and presentation communication skills.
Self-starter who needs minimal supervision.
Self-confident and able to react quickly under pressure.
Must be available to work full-time and commute to or relocate to Sunnyvale, California.
Willingness and availability to travel up to 30%, including some international travel.

Nice To Haves

Experience with on-site clinical trial support.
Experience with commercial product launches.
Familiarity with intellectual property development and patent assessment.

Responsibilities

Lead design and development of new product concepts before commercial launch, using clinical, scientific, and technical expertise.
Research disease states and medical technologies related to new business opportunities and develop expertise in products and their clinical applications.
Collaborate with marketing partners and clinicians to identify and understand marketing needs.
Work with key opinion leaders, subject matter experts, and other stakeholders to identify clinical goals and translate needs into user-centric designs for platforms, procedures, instruments, and accessories.
Collaborate with engineers and physicians to define and evaluate clinical performance goals and potential safety and usability risks for products in early-phase development.
Develop and execute clinical de-risking pathways, including pre-clinical and clinical feasibility studies.
Assess product design iterations internally and with external key opinion leaders.
Develop and execute preclinical evaluation strategies in advance of human trials and regulatory submissions.
Provide subject matter expertise for user manuals and training documentation, and support regulatory documentation and submissions.
Lead and execute early-stage feasibility studies, pilot trials, and pivotal clinical trials to support technology development and regulatory and reimbursement strategies.
Collect and analyze clinical study insights to inform product requirements and training needs, and manage clinical risks in accordance with quality management systems.
Design, develop, and execute clinical evaluations of prototypes and translate feedback for engineering teams.
Identify product enhancements and new product ideas by analyzing clinical needs of physicians and users.
Develop intellectual property for novel clinical applications and technologies.
Keep the organization’s vision and values at the forefront of decisions and actions, and perform other duties as required to support company strategy and goals.