Quality/Manufacturing Engineer Broncus Technologies, Inc.
THIS JOB HAS EXPIRED THE OPPORTUNITY
According to the American Lung Association, lung cancer is the leading cancer killer in both men and women worldwide. In 2010, there were over 150,000 deaths from lung cancer in the United States alone. To diagnose lung cancer, a pulmonologist may order a chest x-ray, a CT scan (a 3-D x-ray), or insert a small tube called a bronchoscope through the nose or mouth to observe the patient?s airways and lungs. The pulmonologist may then take a biopsy of the tumor to examine and diagnose the lung cancer. However, it is currently very difficult to navigate the bronchoscope through redundant, space-constrained airways to take an accurate biopsy.
Broncus Medical has commercialized and continues to develop innovative solutions for diagnosing and treating lung diseases. Physicians use LungPoint Virtual Bronchoscopic Navigation Systems to plan bronchoscopic procedures and quickly and accurately maneuver to tumors in the lungs. LungPoint is a powerful platform for computer-assisted, image-guided bronchoscopic planning and navigation that is intuitive and easy to use. It provides a map and visual directions through the lung airways to a lung tumor. The unique 18 gauge FleXNeedle coring needle enables peripheral sampling and access to hard-to-reach areas of the lungs.
We are looking for a special person to work with a talented team and take a hands-on role in our Operations group. This person will be responsible for assisting with the development, testing, and validation our products and processes and transferring production when applicable. As such, he/she will take ownership of, and significantly contribute to the success of the development and commercialization of our new products. Travel of up to 20% is expected.
THE IDEAL CANDIDATE
The candidate selected to fill this position will have:
Excellent testing, troubleshooting, and failure analysis skills.
Solid Engineering and Quality documentation practices with strong attention to detail.
The ability to assist R&D in the design, procurement and testing of components, processes and assemblies.
Experience developing specifications for custom components, test protocols, work instructions and process controls, and device history records.
The ability to design and document new processes for the fabrication of components and assemblies, and lead qualification, verification, and validation of processes and training of production staff.
Significant DFX (design for assembly, maintainability, etc.) and/or value analysis/value engineering experience.
Experience reviewing product designs for compliance with engineering principles, standards, customer requirements, and related specifications.
The ability to build product and subassemblies for testing, prototyping, and design or process improvements.
Experience assisting in the development and review of protocols for verification and validation testing, performing testing, and writing and releasing reports.
The ability to support regulatory submissions in compliance with all ISO, EN, MDD, and FDA regulations.
Experience in the application of statistical methods such as DOEs, sampling plans, and population comparisons to the medical device product realization process.
Demonstrated the ability to minimize bottlenecks and drive improved first pass yields on a daily basis.
Familiarity with computer-aided medical device applications and their operation is a strong plus.
The willingness to assist in other operational areas as work demands or project timelines vary.
Good interpersonal, verbal, and written English communication skills.
A bachelor?s degree in applicable Engineering or Biomedical field preferred and/or five years of equivalent experience and training.
THE REASONS TO JOIN US
An opportunity to significantly impact the lives of millions of lung cancer patients
A small, startup environment on the verge of growing into a global enterprise
An honest, rewarding, team-based, fun environment
An extraordinary group of employees, advisors, and investors
Equity participation, and competitive compensation and benefits
||Mountain View, CA |
THIS JOB HAS EXPIRED