R&D Engineer II

Imperative Care•Campbell, CA

1d•Onsite

About The Position

Imperative Care is dedicated to changing the way stroke is treated by developing breakthroughs that will revolutionize the future of stroke care. The technologies developed directly impact human lives, with a primary focus on patient needs. As a developing professional, this R&D Engineer II position will be involved in the early phase design and development of neuro-interventional medical devices. The role encompasses contributing to creative brainstorming, conceptualizing, and prototyping new devices, either independently or in collaboration with other engineers. Key responsibilities include problem-solving, hypothesis testing, test method development, design documentation, specification setting, prototyping, testing, data analysis, and report generation.

Requirements

Bachelor’s degree in engineering, or related discipline and a minimum 1 year of related experience; or equivalent combination of education and work experience.
Statistical Analysis Software (Minitab or similar) and CAD (Solidworks, ProE, similar).
Developing knowledge of product design from concept to regulatory marketing approval.
Ability to complete projects individually as well as part of a team, exercising judgment within defined procedures and practices to determine appropriate action.
Ability to apply learned techniques to analysis/investigation to solve challenges using problem-solving tools and methodologies.
Previous experience working with regulated quality systems such as GMPs, ISO 9001, and the MDD.
Familiar with Design Control procedures and requirements.
Demonstrated excellent written and verbal communications skills required.

Nice To Haves

Experience in endovascular or neurovascular techniques and devices preferred.
Skilled knowledge of machine shop equipment (mill, lathe, drill press, etc.) operation including operation of 3D printing equipment is preferred.

Responsibilities

Participate in early phase design and development of neuro-interventional medical devices.
Contribute to creative brainstorming sessions, conceptualizing and prototyping new devices independently or in conjunction with other engineers.
Perform problem solving, hypothesis testing, test method development, design documentation, specification setting, prototyping, testing, data analysis, and report generation.
Work collaboratively with minimal supervision on routine aspects of research, design, and develop new product and improvements for current product, or detailed instruction for in new projects.
Contribute to brainstorming sessions and generate new intellectual property, working with senior staff and/or attorneys in writing and researching patent claims.
Complete detailed specifications, construction of prototypes, and testing of new products or product enhancements, ensuring product documentation adheres to Quality System requirements.
Participate in the design and development of studies and experiments, execute product testing and protocols in accordance with project plans.
Evaluate vendor/contract manufacturer and material choices for designs sharing insights for decision-making.
Collaborate with customers to determine needs in product design, user interface, and possible integration of product with other medical systems or products, interacting with research physicians to identify potential product and further market opportunities.
Contribute to the design new products or product enhancements in a cost-effective and timely manner understanding how the product will be manufactured.
Facilitate user training and oversee the development of supporting materials.
Contribute to the process of transferring product from development to manufacturing.
Ensure engineering testing and documentation is in accordance with regulatory requirements for approvals of products by the US and foreign regulatory agencies.
Complete documentation including design drawings, testing reports, engineering reports, and other technical documents in accordance with quality system requirements.
Review activities of technicians completing device testing/inspection and prototype construction.