Staff Clinical Engineer
San Mateo, CA
Client:
Our client is an innovative, venture capital-funded medical device startup in Burlingame, CA. Their team is building something unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy.
POSITION SUMMARY:
The Staff 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
- Develop clinical hazards analysis and documentation and suggest mitigations to inform product design
- Develop new test methods, models, and metrics for quantifying product performance.
- Own and manage pre-clinical testing facilities including regulatory compliance.
- Lead and execute evaluation of new product and service prototypes
- 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
- Provide mentorship and support the professional development of junior team members
REQUIRED QUALIFICATIONS:
- B.S. in Biomedical Engineering or similar
- 5+ years of work experience in clinical development within the medical device industry
- Strong 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
- Experience developing design validation strategy, protocol creation and testing
- Fluent in medical terminology and sound knowledge of anatomy
- Ability to effectively communicate concepts, ideas, and knowledge to other individuals and teams.
- 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
PREFERRED QUALIFICATIONS:
- Experience in clinical development for medical robotics
- M.S. in Biomedical Engineering or similar
- 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
- Familiar with robotics fundamentals