Principal Clinical Engineer

Imperative Care•Campbell, CA

4d•Onsite

About The Position

This position is based in our Campbell, California offices. This position is on-site & full-time. At Imperative Care, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Imperative Care changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.

Requirements

Bachelor's degree in mechanical or biomedical engineer, or related discipline and a minimum of 12 years of related experience in the medical device or related regulated industry or equivalent combination of education and work experience
Ability to understand the intricate nuances to what is clinically meaningful to physicians who use similar type of technology.
Ability to collaborate effectively with internal and external stakeholders at all levels to accomplish project goals, example: senior management, field experts, investors, regulatory agencies, etc.
Deep knowledge and expertise in execution throughout the product development cycle.
Expert knowledge of product design under ISO 13485 with ability to interpret regulations, guidelines and policy statements (QSR, MDD, and ISO), or any comparable quality systems.
Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings.
Excellent written and oral communication skills with technical writing capabilities.
Ability to prioritize multiple projects independently, and influence others with proven decision making, hands-on and results-oriented work style.

Nice To Haves

Preferred extensive experience in a clinical/technical innovation role, with specific focus on process, GLP, HFU, and/or assessing design and usability of endovascular or neurovascular devices.
Preferred prior experience leading technical teams through the execution of novel technologies.

Responsibilities

Serve as the subject matter expert when establishing and implementing project plans for product development including preclinical testing, bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.
Oversee budget spending for pre-clinical projects and to ensure appropriate resources are used for the continuous development and improvement of internal testing capabilities.
Contribute to strategies for the clinical use of products and recommend solutions that align with Company objectives.
Collaborate with internal and external multi-disciplinary teams, with a broad scope of discretion, to identify critical issues and communicate project advancements.
Provide regular updates to management regarding project status, and critical issues that may affect attainment of project completion dates. Collect input and direction to revise tactical plans for projects to move forward.
Create and execute design verification and testing plans, leading team meetings where progress is discussed, decisions are made, and updates are communicated.
Ensure project teams are conducting pre-clinical testing of new products within the design control and applicable quality standards, and products are designed, developed, tested, manufactured and documented according to applicable global regulatory requirements.
Participate in the hiring, training and performance management of assigned team aiming toward productively achieving department goals.
Stay current on information related to high quality pre-clinical testing capabilities.