Principal R&D Engineer, Preclinical

at  Imperative Care

Title: Principal R&D Engineer, Preclinical
Location: This position is based in our Campbell, California offices. This position is on-site & full-time with some travel.

You will be responsible for contributing to all pre-clinical related research, design and testing to further the conceptualization, design, development, and manufacturability of product/s in accordance with the company’s Quality System and customer requirements.

You will be responsible for designing and managing all aspects of physician evaluations, in-vitro bench and simulated use testing, and in-vivo studies, and will partner with Marketing representatives to create marketing collateral via bench and in-vitro testing.

• Design and manage in-vitro (in-house and external) and in-vivo testing: study design and model selection (including model design/development as needed)
• Coordinate, design and manage internal and external resources, as well as generation of protocols, and reports, in addition to overseeing the testing lab
• Collaborate with project teams to prepare and conduct physician evaluation sessions, including method/test sequence development, model design and selection, and data collection
• Significant interaction with customers, study centers, etc, coordinate study schedules, seeking and providing input into our processes
• Work directly with customer representatives to determine needs in simulated use/in-vitro testing, product design, user interface, and possible integration of product with other medical systems or products

What You’ll Bring

• BS in Engineering or related discipline and 12+ years of related experience; or MS in Engineering with 8+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry.
• 5+ years previous experience in medical device pre-clinical engineering related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc.)
• Prior experience working with physicians in OR setting strongly preferred
• Knowledge of and exposure to product testing and data collection
• Extensive experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
• Extensive experience in full R&D product life cycle

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Salary Range: $176,000-191,000
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate’s work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.
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