CAREER OPPORTUNITIES

If you are passionate about making a difference in the lives of patients with lung cancer, join our team.  Click below for details on current open positions.  If you are interested in a position at Broncus that is not listed below, send your resume to hr@broncus.com.


R&D Imaging Software Engineer

We are looking for a talented person who can design and implement a 3D medical software tool, and take a hands-on role in our Software Development group. The successful candidate will have extensive experience in general software development, medical image analysis, and statistical learning/machine learning.

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THE IDEAL CANDIDATE

The candidate selected to fill this position will have:

  • Master or PhD in Computer Science and Engineering, Electrical Engineering, Biomedical Engineering, or related fields.
  • Experience with software development process in a regulated environment
  • Familiarity with 2D and 3D medical images analysis.
  • Experience with multithreaded and multi-process programming.
  • Expertise in Machine Learning and Image Analysis techniques in the medical domain is a big plus. Specialties may include feature extraction, segmentation, visualization, surgical planning, or related disciplines.
  • Fundamental knowledge of and experience with data structures and algorithms.
  • Superb problem solving abilities in complex systems
  • Flexibility in contributing to the project and determination to drive tasks to solution
  • Experience with VTK, ITK or other graphics and image processing tools is a plus
  • Experience in DICOM and database is a plus

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

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Regulatory Affairs Manager

The position is responsible for supporting regulatory activities including country registrations, maintaining commercial technical files, and ensuring compliance to applicable regulations.

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Essential Duties and Responsibilities: (Other duties may be assigned)

  • Support country registrations in EU: Maintain current approvals, obtain approval in targeted countries.
  • Support country registrations in Asia/China: Provide appropriate requested documentation from Broncus China. Ensure appropriate approvals are garnered prior to release of product.
  • Maintain commercial technical files
  • Support regulatory activities a needed/directed by VP or Sr Mgr Regulatory (i.e. submissions, registrations, etc.)
  • Maintain FDA registration and export documentation as needed.
  • Support labeling activities (including IFU), publications and promotional material to ensure claims related to medical device safety and efficacy can be substantiated
  • Maintain external standards and ensure compliance for emphysema and lung cancer
  • Maintain current essential requirements documents for EU and TGA
  • Ensure export/import compliance for commercial and investigational devices
  • Participate in risk management reviews and assessment of complaints
  • Prepare and submit annual reports
  • Support review of clinical documentation including protocols and reports.
  • Review plans, FMEAs, verification and validation protocols and reports, for internal consistency, standards application and effects on submissions.

Minimum Education and/or Experience:

  • Bachelor’s degree required.  Course program(s) or advanced training in Regulatory Affairs preferred.
  • Minimum 5 years experience in the medical device industry with 3 years in regulatory affairs role.

Licenses/Certifications: N/A

Supervisory Responsibilities:

  • N/A

Special Requirements/Physical Demands/Working Conditions:

  • Minimum travel required, domestic.

Communication Skills:

  • Must have excellent verbal and interpersonal skills.
  • Ability to work successfully with a variety of internal and external sources

Administrative and Technical Skills:

  • Previous FDA and OUS submission experience.
  • Ability to manage multiple priorities in a high pressure environment.
  • Working knowledge of current revisions of:
    • EN ISO 13485 Medical Devices – Quality Management System
    • MDD 93/42/EEC: Medical Devices Directive
    • Title 21 CFR Part 820: FDA Quality System Regulation
    • EN ISO 14971 Medical Devices – Application of Risk Management to Medical Devices

Reasoning Ability and/or Critical Thinking:

  • Ability to contribute and collaborate in a creative, fast-paced and team oriented environment.
  • Excellent problem-solving skills.
  • Ability to create and execute effective plans to address issues/goals.

Apply for this position

First Name*

Last Name*

Email address*

Phone Number*

Upload your Resume*

Your Cover Letter*