Sr. R&D Engineer (Medical Device)

Spirair•South San Francisco, CA

16h•Onsite

About The Position

Spirair, a venture capital-backed medical device company, co-founded by two Stanford Biodesign and Innovation fellows, is seeking a Sr. R&D Engineer. This role is responsible for the design, development, and manufacturability of products, ensuring they meet customer and manufacturability requirements. The engineer will interact with other disciplines, potentially interface directly with suppliers and physicians, and contribute to a growing startup at an exciting stage of development.

Requirements

Bachelor’s degree in Engineering or equivalent.
At least 5 years of medical device R&D experience.
Proficiency in SolidWorks for solid models and dimensioned drawings.
Good communication and documentation skills.
Strong computer skills and electronic data capture experience.
Ability to multi-task and prioritize with flexibility required in a start-up environment.
Proficient in Microsoft Word/Excel/PowerPoint.
Legal authorization to work in the US is required.
Must not require sponsorship for employment visas.

Responsibilities

Design and develop new products from concept to market release that address market and customer needs.
Design and implement new methodologies, materials, and processes to support product development and transfer to manufacturing.
Actively participate and contribute to idea generation such as through brainstorming and IP development.
Use data-based recommendations when contributing to design change decisions.
Design and build test and assembly fixtures for both product development and manufacturing.
Ensure design control requirements are met, manage product development timelines and work with a cross functional team to bring new devices to commercialization in a timely fashion.
Work within aggressive timelines to manage product development projects.
Timely communication of project progress and issues to management.
Test designs to validate the ability to function as intended and offer design modifications to meet specific market needs.
Perform verification testing to establish that new devices meet design input specifications.
Conduct feasibility studies throughout the development process to ensure desired functionality and vet possible enhancements (this includes planning of outside animal and cadaver studies).
Develop tools, if required, to accompany marketed device.
Create detailed documentation throughout the various stages and steps in research and development.
Work closely with manufacturing to ensure smooth transitions to commercial production.
Assume other projects/assignments as assigned.
May be required to provide technical support for regulatory, clinical or sales efforts.
Document invention disclosures to contribute to intellectual property portfolio.