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Spirair logoSpirair

Sr. R&D Engineer (Medical Device)

South San Francisco, California, United States · Hybrid

$115k–$150k/yr

Senior$13M raised

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.…

Skills: SolidWorks, Medical Device R&D, Product Design, Design Control, Verification Testing

Spirair logo

Sr. R&D Engineer (Medical Device)

Spirair

South San Francisco, California, United States • Hybrid

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  • $115k–$150k/yr
  • Full-time
  • bachelor degree
  • Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off, 401(k)
  • Posted 9d ago
  • ~40 hrs/week

Responsibilities

Responsible for the design, development, and manufacturability of medical devices from concept to market release. This includes managing product timelines, conducting verification testing, and collaborating with cross-functional teams and suppliers.

Requirements

Requires a Bachelor's degree in Engineering and at least 5 years of medical device R&D experience. Proficiency in SolidWorks and strong communication skills are essential for success in this startup environment.

Full 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 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.

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.

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.

Related keywords

Medical DeviceR&DSolidWorksDesign ControlVerification TestingFeasibility StudiesIP DevelopmentManufacturingENTBiodesignProduct DevelopmentCADRegulatory SupportClinical SupportStartup

About Spirair

LinkedIn

Shaping the future of ENT

Industry
Medical Equipment Manufacturing
Company size
11-50 employees
Headquarters
South San Francisco, CA
LinkedIn followers
2,645
Total funding
$13M

Spirair is an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients by providing strong outcomes and a better patient experience. We’re committed to developing new therapies that can easily integrate in any ENT’s treatment algorithms so they can help more of their patients breathe better. Spirair got its start in the Stanford Biodesign Innovation Fellowship, a program that equips aspiring innovators with a proven, repeatable process to identify important health-related needs, invent novel health technologies to address them, and prepare to implement those products into patient care. Founders James Kintzing, Ph.D. and Brandon McCutcheon, M.D. were co-fellows in the program and identified an opportunity in the ENT space when they discovered the unmet need for a minimally invasive nasal septal deviation correction therapy to help address nasal airway obstruction. Our first product is a novel solution for symptomatic nasal septal deviation (NSD) that supports and straightens minor deviations in the septal cartilage. The procedure can be conveniently and safely performed under local anesthesia or in any site of service as part of standard septoplasty techniques.

Offices: South San Francisco, CA, US

Health CareMedical DeviceWellness
View all jobs at Spirair

About Spirair

LinkedIn

Shaping the future of ENT

Industry
Medical Equipment Manufacturing
Company size
11-50 employees
Headquarters
South San Francisco, CA
LinkedIn followers
2,645
Total funding
$13M

Spirair is an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients by providing strong outcomes and a better patient experience. We’re committed to developing new therapies that can easily integrate in any ENT’s treatment algorithms so they can help more of their patients breathe better. Spirair got its start in the Stanford Biodesign Innovation Fellowship, a program that equips aspiring innovators with a proven, repeatable process to identify important health-related needs, invent novel health technologies to address them, and prepare to implement those products into patient care. Founders James Kintzing, Ph.D. and Brandon McCutcheon, M.D. were co-fellows in the program and identified an opportunity in the ENT space when they discovered the unmet need for a minimally invasive nasal septal deviation correction therapy to help address nasal airway obstruction. Our first product is a novel solution for symptomatic nasal septal deviation (NSD) that supports and straightens minor deviations in the septal cartilage. The procedure can be conveniently and safely performed under local anesthesia or in any site of service as part of standard septoplasty techniques.

Offices: South San Francisco, CA, US

Health CareMedical DeviceWellness
View all jobs at Spirair

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