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.


Senior Manufacturing Engineer

We are looking for a talented person who can plans, directs, coordinates, and executes manufacturing engineering activities related to new product development and sustaining existing product by performing the following duties:

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

  • Develops, evaluates, and documents manufacturing methods for new products in development. Owner of authoring documentation required for finished goods production.
  • Partners with design staff concerning product design and process designs to ensure efficient, repeatable and cost effective production methods.
  • Develops and drives process validation of new products or repeat validation of existing products. Drives authoring of protocols, completion of testing, and authoring reports to support validation and transfer phases of development.
  • Design, plan, and support transfer to foreign MFG facility or contract manufacturer as required by business plan. Travel will be required to foreign countries such as China to support these transfer activities.
  • Troubleshoots mfg. issues and is owner of research, testing and/or analysis to resolve. Implements resolution in DMR with required justification and background to support.
  • Analyzes space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency
  • Mini Design Projects such as accessories to existing products, redesign of sub parts to large assemblies or cost reductions.
  • Leads resolution of manufacturing and process issues.
  • Applies statistical methods where required by standard or standard practice. Applies statistical methods such as DOEs to understand manufacturing requirements and improve processes.
  • Provides technical support to the Purchasing and Quality Assurance for supplier selection, cost negotiation, and quality problem resolution.
  • Responsible for managing projects associated with tooling and fixturing, automation, manufacturing processes, process improvement, cost containment, yield improvement, and scrap reduction.
  • Interacts with vendors to determine or refine specifications and arranges for purchase of equipment, materials, or parts, and qualifies processes as required.
  • Responsible for IQ, OQ of capitalized business equipment, and critical manufacturing equipment, fixtures and tools.
  • Supports the regulatory submission process in compliance with all ISO, EN, MDD and FDA regulations and requirements by gathering data, assisting in the completion of submissions, and meeting goals set forth by project management
  • Responsible for development of manufacturing support documentation, working with engineers to identify best-fit suppliers and sourcing of materials to ensure product quality, cost, manufacturing and delivery requirements are met.

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 in engineering with minimum of 8 years experience or AA with minimum of 10 years of experience. Must have 3+ 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.

Language Ability:

Ability to read, analyze, and interpret manufacturing instructions, CAD drawings, spreadsheets, business memos, reports, technical procedures, and simple legal documents. Ability to write protocols, reports, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers and customers. Ability to respond to general inquiries or complaints from production staff and other team members.  Ability to effectively present information to top management.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables simultaneously.

Computer Skills:

Word processing, spreadsheet, Internet, e-mail, manufacturing, and Solidworks or other CAD

Supervisory Responsibilities:

This job has no supervisory responsibilities.

Work Environment:

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

While performing the duties of this job the employee is occasionally exposed to moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals as well as potentially biohazardous human and animal tissue.

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 70 pounds. The vision requirements include: ability to adjust focus, depth perception, distance vision, close vision, and microscope use.

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Senior Quality Engineer

The position is responsible for Quality Engineering activities in the design, development and manufacture of products to ensure high-level product quality and compliance to FDA QSR and ISO 13485 in all assigned areas. Work closely with Operations and R&D on new product activities and support production and continuous quality improvement.

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

• Participate on product development projects to ensure specifications, test procedures and manufacturing documentation are properly established and compliant with applicable regulations.
• Participate in risk management for identifying hazards, analyzing, evaluating and controlling risks, as well as for monitoring the effectiveness of risk control throughout the Quality Management System and product and/ or project lifecycle.
• Maintain state of the art in applicable external standards per the requirements of MDD and managing the gap assessment of new or revised standards.
• Assist with biocompatibility and sterilization validation efforts.
• Participate in the development of corrective and preventative action plans and coordinate closure of actions with assigned responsible parties.
• Provide leadership in the improvement of product quality through proactive means as well as post analysis, investigation and corrective action.
• Support and improve the existing quality system in accordance with the existing standards and regulations.  Provide guidance for clinical and market release submissions based on your knowledge of applicable standards.
• Assist in the development, and improvement of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, non-conforming materials, product lot release testing, and finished goods control.  Identify and develop test methods and fixtures as needed. Manages the calibration / preventative maintenance program. Lead the Materials Review Board, and review/approve nonconforming material and related system documentation.
• Draft process validation plans and protocols, and conduct validation testing of new or update products as necessary.
• Responsible, along with the Supplier Chain Manager, for maintaining supplier relationships and providing supplier qualifications and audits.
• Tracks and reports on quality and business measurements such as complaints, in-process defects, field failures, and non-conforming materials. Manages the Complaint and RMA process.
• Manages the Internal Audit program. Participates in internal audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications. Participates in external audits.

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.
• Experience in Medical device industry, thorough knowledge and experience working with US FDA Regulations (QSRs), ISO 13485.
• Experience in FMEA risk management, auditing suppliers and validation process.
• Experience in Catheter and Software quality assurance a plus.
• Design of Experiments & Process Validation background a plus.
• Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
• Ability to work successfully as part of a small team, with a willingness to jump in wherever needed.
• A drive to get the job done in the face of obstacles and time constraints.

Education/Experience:

Engineering degree or equivalent, with 5+ years of experience or more.

Language Ability:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to effectively present information to top management and public groups.

Reasoning and Technical Ability:

Ability to define problems, collect data, establish facts, and draw valid statistical conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form. Ability to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associated with these documents.

Computer Skills:

Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software

Supervisory Responsibilities:

May supervise 1 or more employees in the Quality Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Work Environment:

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

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and occasionally exposed to caustic or toxic chemicals.

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 regularly required to stand; sit and use hands to finger, handle, or feel. The employee is occasionally required to reach with hands and arms. The employee is frequently required to lift up to 25 pounds. The vision requirements include: ability to adjust focus, depth perception and close vision.

Accommodations:

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

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First Name*

Last Name*

Email address*

Phone Number*

Upload your Resume*

Your Cover Letter*