Principal 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 Principal R D Engineer 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 assigned products are designed to meet customer requirements as well as manufacturability requirements. Provide technical guidance to less experienced colleagues in the R D group. 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. This position requires a high level of professionalism and independence. Project planning duties are required. Requirements

MAJOR DUTIES AND RESPONSIBILITIES

Design and develop new products, as well as product changes and enhancements and manufacturing processes which are consistent with a zero-defect level as well as low product cost. Solve complex problems at the product level and oversee development process through to the manufacturing stage. Design and develop test methods which accurately evaluate performance. Generate effective testing protocols and reports. Analyze test results utilizing DOE and statistical methodology. Train and supervise assigned technicians and temporary workers on new test methods and manufacturing processes. Conduct design review meetings. Provide technical guidance and recommendations to management. Manage and act as a mentor to other engineers. Complete projects (including product enhancements) in an aggressive manner consistent with corporate objectives. Independently determine day-to-day tasks. Contribute to the intellectual property position of the company via invention disclosures and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes. Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Spirair's products. Provide engineering and technical support of products introduced into both the domestic and international markets. Procure and oversee outside vendors and consultants as required. Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. Provide support in the resolution of product complaints and/or safety issues. Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, ISO, and FDA regulations. Maintain a professional, credible image with key physicians, consultants, vendors, and co-workers. Perform other duties as assigned.

PREFERRED QUALIFICATIONS

Education and/or

Job Experience:

Bachelor's degree in Engineering, Biology, or other science, or equivalent. Master's degree preferred. 10-15 years related experience in the medical device industry.

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, equity, 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 $150,000 - $180,000. 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.