Clinical Research Engineer

Primary Function of Position

The Clinical Research Engineer within our Future Forward organization will lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical scientific and technical expertise. This individual will collaborate closely with product management engineers physicians interaction designers human factors training and technical publication specialists and various internal and external stakeholders to guide product and procedure development. The Clinical Research Engineer individual will develop and execute pre-clinical experimental strategies to evaluate device performance safety and usability through the Product Development Process (PDP) ensuring readiness for early feasibility studies. This individual will also play a key role in proctoring early-stage feasibility clinical studies gathering case insights to support technology advancement identifying and documenting user needs managing product requirements assessing clinical risks and providing design guidance for clinical and commercial design and development. The Clinical Research Engineer will also work with cross-functional teams including regulatory quality medical and clinical affairs and finance to shape clinical indications and commercialization strategies driving the technology from concept to a commercial-ready product.

Essential Job Duties

Pre-clinical research and commercial concept development :

Lead the design and development of new product concepts prior to early feasibility studies and commercial launch by leveraging in-depth clinical scientific and technical expertise.

Research disease states and medical technologies associated with new business opportunities to become an expert on new 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 those needs into user-centric designs for new platforms procedures instruments and accessories.

Collaborate closely with engineers and physicians to define and evaluate clinical performance goals potential safety and usability risks for new products in early-phase development.

Create novel clinical models and metrics for evaluating technology and prototype performance.

Develop and execute clinical derisking pathways including pre-clinical and clinical feasibility studies to ensure technology advancement and readiness for commercial launch.

Conduct design iteration assessments of products both internally and with external key opinion leaders.

Develop and execute preclinical evaluation strategies for human trials and regulatory submissions.

Provide subject matter expertise to user manual and training documentation development.

Support regulatory documentation and submissions.

Demonstrate an analytical approach to identify potential product enhancements and new product ideas.

Clinical research and innovation :

Lead and execute early-stage feasibility clinical studies pilot and pivotal clinical trials to support technology development for regulatory and reimbursement strategies.

Identify and drive product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users.

Collect and analyze clinical study insights to inform new product requirements training needs manage clinical risks adhering to quality management systems.

Design develop and execute clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration.

Develop intellectual property for novel clinical applications and technologies.

Others :

Keep the organizations vision and values at the forefront of decision making and action.

Perform other duties as required to support the companys overall strategy and goals.

Qualifications :

Required Skills and Experience

Fluent 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 use of the product.

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.

Product development and Design Controls experience.

Effective communication skills (verbal written presentation).

Self-starter needing minimal supervision.

Self-confident and able to react quickly under pressure.

Required Education and Training

Minimum of a B.S. in Biomedical Engineering Mechanical Engineering or similar.

At least 5 years of related experience in clinical engineering and / or product development within the medical device industry.

Preferred Skills and Experience

Experience with on-site clinical trial support a plus.

Experience with commercial product launch a plus.

Familiar with intellectual property development and patent assessment

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.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer :   In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note : the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note : typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and / or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

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.

Remote Work : No

Employment Type : Full-time

Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Experience : years

Vacancy : 1