Sr. R&D Engineer (Medical Device)

Spirair, a venture capital backed medical device company, was co-founded by two Stanford Biodesign and Innovation fellows with a shared interest in optimizing outcomes and patient experience through innovation solutions. With a passion for developing elegant technologies that evolve care and enhance accessibility and effectiveness, the Spirair team is partnering with leading ENT advisors and industry veterans to offer treatment options that are both massively impactful and minimally invasive.We are hiring for a Sr. R&D Engineer who will be responsible for the design, development and manufacturability of specific products in accordance with the company's Quality Manual (i.e., the quality system). This position will ensure that products are designed to meet customer requirements as well as manufacturability requirements. Interact with other disciplines within the company to ensure appropriate process development and feedback. Direct interface with suppliers as well as customers (physicians) may be required.RequirementsMAJOR DUTIES AND RESPONSIBILITIES:Design new device product(s) and build prototype to address a market need. Design and implement new methodologies, materials, machines, processes or productsDevelop new concepts from initial design to market releaseActively participate and contribute to idea generation such as through brainstorming and IP developmentUse data-based recommendations when contributing to design change decisionsDesign and build test and assembly fixtures for both product development and manufacturingEnsure 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 fashionWork within aggressive timelines while adhering to project management principles of providing good estimates of task duration and informing early of issues in meeting the scheduleTest designs to validate the ability to function as intended (including generating and reviewing test protocols) and offers design modifications to meet specific market needsVerify the integrity of the device to function with predicable resultsConduct feasibility studies throughout the development process to ensure desired functionality and possible enhancements (this includes planning of outside animal and cadaver studies)Fabricate tools, if required, to accompany marketed deviceCreate detailed documentation throughout the various stages and steps in research and developmentWork with manufacturing/production in an advisory capacityParticipate in manufacturing builds as requiredAssume other projects/assignments as assigned or as determined to be appropriate to the company and/or positionMay be required to provide technical support for regulatory/clinical or sales effortsDocument invention disclosures to build intellectual propertyPREFERRED QUALIFICATIONS:Education and/or Job Experience:Bachelor's degree in Engineering or equivalentAt least 5 years of R&D experience preferredSkills, Abilities, and Requirements:Proficiency in SolidWorks for solid models and dimensioned drawingsGood documentation skillsStrong computer skills and electronic data capture experienceAbility to multi-task and prioritize with flexibility required in a start-up environmentProficient in Microsoft Word/Excel/PowerPointBenefitsSpirair offers highly competitive salaries and benefits, including medical, dental, and vision insurance, paid time off, and 401(k). Legal authorization to work in the US is required. We are not able to sponsor individuals for employment visas for this job. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment verification form upon hire.We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.The expected base salary range for this role is $115,000 - $150,000. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. This position is based in our South San Francisco, CA location.