Sr. R&D Engineer (Medical Device)

Job Description Job Description 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. Requirements MAJOR 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 products. Develop new concepts from initial design to market release. 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 while adhering to project management principles of providing good estimates of task duration and informing early of issues in meeting the schedule. Test designs to validate the ability to function as intended (including generating and reviewing test protocols) and offers design modifications to meet specific market needs. Verify the integrity of the device to function with predicable results. Conduct 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 device. Create detailed documentation throughout the various stages and steps in research and development. Work with manufacturing/production in an advisory capacity. Participate in manufacturing builds as required. Assume other projects/assignments as assigned or as determined to be appropriate to the company and/or position. May be required to provide technical support for regulatory/clinical or sales efforts. Document invention disclosures to build intellectual property. PREFERRED QUALIFICATIONS: Education and/or Job Experience: Bachelor’s degree in Engineering or equivalent. At least 5 years of R&D experience preferred. Skills, Abilities, and Requirements: Proficiency in SolidWorks for solid models and dimensioned drawings. Good 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. Benefits Spirair 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.