Product Development Engineer Jobs in Berkeley, CA

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 a Sr. R&D Engineer who will be responsible for the design, development, and manufacturability of products, ensuring that products are designed to meet customer and 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. This is an excellent opportunity to join a growing startup company at an exciting time in its development.

Requirements

MAJOR DUTIES AND 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.

PREFERRED QUALIFICATIONS

Education and/or Job Experience:

• Bachelor’s degree in Engineering or equivalent.
• At least 5 years of medical device R&D experience.

Skills, Abilities, and Requirements:

• 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.

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.