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 email@example.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.Read more details and apply for this position
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
Apply for this position
Regulatory Affairs Manager
The position is responsible for supporting regulatory activities including country registrations, maintaining commercial technical files, and ensuring compliance to applicable regulations.Read more details and apply for this position
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.
Special Requirements/Physical Demands/Working Conditions:
- Minimum travel required, domestic.
- 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.