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.


Buyer/Planner

Executes the supply chain needs for the Operations Department and the company to ensure materials availability so products can be efficiently manufactured to meet company and customer demand.

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

  • Materials management using Excel spreadsheets and data entry into Quickbooks Enterprise (inventory module).
  • Responsible for planning, sourcing, production and delivery to ensure product quality, cost and delivery requirements are met
  • Provide staff with status reports of material usage
  • Generate and Track POs for Materials management and inventory needs. Maintain accurate inventory records including maintenance and use of manual inventory system and planner to track inventory movement. Define requirements for a future MRP/ERP system.  Perform periodic inventory count. Add new products to system via collaboration with Finance.
  • Responsible for maintaining the Purchase Order process and ensure that requests are valid and meets procedural requirements. Review and approve purchases up to specified dollar ceiling and facilitate the approval process
  • Receive incoming materials and documentation and maintain warehouse organization.
  • Maintain and coordinate off site logistics/storage. Maintain inventory count of offsite logistics location(s)
  • Shipping to and from customers both domestic and international including any requirements for international shipping documentation.
  • Collaborate with Operations personnel to recommend and measure overall materials and finished goods inventory
  • Communicate with Operations Team to ensure that inventory of parts meets production needs
  • Review new component specifications and unit production forecasts to determine needs for the materials (supply chain) stakeholder’s perspective.
  • Identify qualified vendors and negotiate best price for products/services. New supplier qualifications. Request bids from new suppliers.
  • Monitor and maintain the sales use tax status of vendors per Finance direction
  • Maintain ASL to ensure certification and information accuracy. Maintain supplier relationships including visits. May support Supplier audit
  • Perform monthly audits of supplier files to review approval status and keep up to date
  • Support company goals and objectives, policies and procedures, and FDA regulations
  • Perform other duties as assigned

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education/Experience:

BS degree with minimum of 5 years experience or AA with minimum of 7 years of experience.  Must have 2+ years of hands-on medical device or pharmaceutical company experience.  Must be able to multi-task and operate in a fast startup environment with minimal training and supervision. APICS or ISM certification is a plus.

Language Ability:

Ability to read, analyze, and interpret manufacturing instructions, CAD drawings, spreadsheets, business memos, reports, and simple legal documents.  Ability to respond to general inquiries from production staff and other team members.  Ability to effectively present information to management.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret simple technical instructions in mathematical or diagram form.

Computer Skills:

Word processing, Excel spreadsheets, Internet, e-mail, manufacturing, and MRP/ERP system. Quickbooks Enterprise with inventory module experience is required.

Supervisory Responsibilities:

No supervisory role.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job the employee is frequently required to stand; sit and use hands to manipulate objects. The employee is occasionally required to lift up to 70 pounds.

Accommodations:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Quality Engineer

This position supports Broncus Medical, Inc., and Uptake Medical.

In this role, you will be responsible for managing and maintaining product complaint processes with an emphasis on continuous improvement, and efficiency to meet the current and future needs of the business. Key activities will include the daily processing of complaints and RMAs including Service Reports related to complaints to ensure that issues are being addressed in a timely and thorough manner and conform to complaint policy and requirements. This role has direct interaction with our internal customers, such as Customer Support and Field support on a regular basis.

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

  • Ensure the Complaints Handling process runs smoothly, and complaints are handled in a timely manner
  • Responsible for processing complaints to assure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner.
  • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
  • Prepare incident reports – FDA (Medical Device Reporting – MDR) and EU (Vigilance Reports) Reports, as needed.
  • Interfaces directly with internal and external customers and indirectly with regulatory agencies, as required.
  • Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
  • Partner with cross-functional departments such as Engineering, Clinical, and Field Specialists on investigating product complaints and ensuring the timely completion and closure of complaint activities.
  • Review Returned Materials Authorizations (RMA) against Customer complaints including related Service Reports and process accordingly. Maintain and file records in a timely manner.
  • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
  • Assist in Quality System audits with various government agencies, private companies, and consultants.
  • Identify, generate and publish metrics and reports related to the Quality issues such as complaints, field failures, and nonconforming materials.
  • Analyze and trend post-market surveillance data.
  • Supports the conduct, documentation, and closure of field correction and removal (recall) activities when needed.
  • Manage documentation on all recalls, product safety issues, field actions and failures to health authorities as required.
  • Execute validation testing of new or update to existing products (Device and Software).
  • Responsible for maintaining state of the art in applicable external standards per the requirements of MDR and managing the gap assessment of new or revised standards.
  • Perform manufacturing audits – when needed
  • Responsible, along with the Supplier Chain Manager, for maintaining supplier relationships and providing supplier qualifications and audits. Interface with Suppliers for new processes, quality issues and process improvements for assigned projects
  • Performs other duties as required

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Education and/or Experience:

  • Bachelor of Science degree or related area of study or equivalent experience
  • 3-5 years of related work experience with complaint handling, MDR/Vigilance reporting for a medical device company
  • Excellent written and oral communication skills along with good presentation and technical writing
  • Works independently in a team environment.
  • Takes initiative and proactively seeks quality solutions through continuous improvement
  • Effective priority setting
  • Must have good analytical and problem-solving skills
  • Strong working knowledge of Microsoft Office applications

Communication Skills:

This position requires excellent written and verbal communication.  Ability to effectively present information in one-on-one and small group situations to suppliers and other employees at all levels of the organization.

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

Reasoning and Technical Ability:

  • Ability to manage multiple priorities in a high pressure environment.
  • Requires high degree of technical comprehension of appropriate ISO and FDA medical device regulations, safety standards of FDA’s GMP regulations (QSR 820), 21 CFR 803 (Medical Device Reporting) and IS013485
  • Ability to write clear logical investigation and technical reports Excellent verbal and written communication skills Strong organizational skills along with strong attention to detail
  • 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.
  • Working knowledge of current revisions:
    • EN ISO 13485 Medical Devices – Quality Management System
    • MDD 93/42/EEC: Medical Devices Directive
    • MDR EU 2017/745
    • EN ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
    • 21 CFR Part 820: FDA Quality System Regulation
    • 21 CFR Part 803, Medical Device Reporting.
    • IEC  62304, Medical Device Software – Software Life Cycle Processes
    • AAMI TIR 32, Software Risk
    • Knowledge of Vigilance (MDD) and TGA Reporting Requirements
    • FDA Guidance, General Principles of Software Validation
    • FDA Guidance, Off-the-shelf Software use in Medical Devices


Computer Skills:

  • Word processing, Spreadsheets, Internet software, E-mail, database software

 

Supervisory Responsibilities:

  • None

Work Environment:

  • Minimum travel may be necessary

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

The noise level in the environment is moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job the employee is frequently required to stand; sit and use hands to finger, handle, or feel. The employee is occasionally required to lift up to 50 pounds. The vision requirements include: ability to adjust focus, depth perception, distance vision and close vision.

Accommodations:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply for this position

First Name*

Last Name*

Email address*

Phone Number*

Upload your Resume*

Your Cover Letter*