Clinical Development Engineer 2

Neptune Medical is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team Triton Robotics at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.

TITLE:  Clinical Development Engineer II

POSITION SUMMARY: The Clinical Development Engineer will work closely with product development teams and clinicians to evaluate product designs from early feasibility to clinical trials to commercialization.  Their primary focus is to understand user needs, establish clinical requirements, consider clinical risks, and identify solutions to guide product development.

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES:

• Collaborate with Product Development and Clinicians to define user needs for product
• Drive product discovery in collaboration with product management and product development teams by being the internal champion of clinical need
• Become the subject matter expert on GI anatomy, disease states, and clinical procedures and environments
• Utilize clinical knowledge to lead the development of bench models for evaluation of prototypes
• Remain current with the latest GI scientific publications relevant to the company’s products
• Assess potential clinical risks and propose mitigations as an input to product design
• Develop new test methods, models, and metrics for quantifying product performance
• Own and manage pre-clinical testing facilities
• Write plans, protocols, conduct formal testing, and report results of preclinical, formative, summative, and validation studies throughout the design process
• Support developing customer training materials, user manuals, labeling, and other supporting materials
• Support initial product launch by developing customer training activities, supporting initial cases during customer site bring up, and conducting Physician Preference Testing

REQUIRED QUALIFICATIONS:

• B.S. in Biomedical Engineering or similar
• 2+ years of work experience within the medical device industry
• Experience collaborating with physicians and collecting feedback on clinical use of the product
• Experience leading hands-on product evaluation testing in a pre-clinical lab
• Fluent in medical terminology and sound knowledge of anatomy
• Excellent verbal and written communications skills required including presentation of technical content
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
• Takes initiative and acts quickly to drive to solutions with a driven outlook and with a strong desire to succeed as an engineer, as a team player, and as a key part of a company
• An inventive aptitude balanced with discipline and detail-orientation
• A self-starter needing minimal supervision and able to adapt priorities in a fast paced, dynamic product development team.

PREFERRED QUALIFICATIONS

• M.S. in Biomedical Engineering or similar
• Experience developing design validation strategy, protocol creation and testing
• Experience in clinical development for medical robotics
• Experience in the regulated medical device environment, including but not limited to document control processes, design control processes, protocol development, and report writing
• Experience developing bench models of disease states
• Experience or knowledge of the GI/endoscopy space
• Experience in conducting risk assessments
• Experience and application of usability and human factors principles

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

Our job titles may span more than one career level. The starting base salary for this role is between $110,000 and $160,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.