Careers

Thank you for your interest in AirXpanders Inc. We are always looking for bright new talent to join our team. Please send your resumé and a cover letter to info@airxpanders.com. We look forward to hearing from you!

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Currently Available Positions

- Controller
- Director of Regulatory Affairs and Quality Assurance
- Document Control Specialist
- Manufacturing Engineer

See descriptions below:

 

AirXpanders Inc.  Controller

Position Title:                       Controller
Reports to:                            President / CEO
Department:                         G&A

PURPOSE OF Job:  Oversee all financial operations of the Company.  Ensure that the Company has adequate systems and procedures to accommodate financial reporting requirements.

 MAJOR DUTIES AND RESPONSIBILITIES:

  • Supervise financial operations staff. 
  • Develop and maintain financial accounting systems that support the Company’s goals and reporting requirements.
  • Accounts Payable processing
  • Payroll management
  • Expense report processing and reconciliation
  • Receivables
  • International wire transfers
  • Monthly close, quarterly comparisons and annual financial metrics
  • Develop detailed financial, cost, budget and accounting reports for management review.
  • Interpret operating results from a financial perspective.
  • Develop financial reports needed to implement business plans and allocate funds.
  • Monitor asset acquisition and disposal, and related depreciation and amortization schedules. 
  • Advise senior management regarding financial objectives and fiscal policies of the Company.
  • Work with each function on the attainment of financial goals and responsibilities
  • Develop global sales and market analytics that support revenue plans.
  • Manage all financial audits, valuations, stock pool distribution and delivery of investor reporting activities. 

 EDUCATION REQUIREMENTS:  Bachelors degree in business equivalent experience.  CPA preferred, MBA a plus.

 EXPERIENCE REQUIREMENTS:  Minimum of 7 years of related experience (preferably in the medical device industry)  in addition to at least three years of management experience. Start-up medical device company experience preferred.  Demonstrated ability to thrive in a fast paced, dynamic environment.

 OTHER QUALIFICATIONS:  Working knowledge of Generally Accepted Accounting Principles is required.  Can bring relationships to bear for banking, audit and service needs of the company.

Job Title:      Director of Regulatory Affairs and Quality Assurance
                       (ISO Management Representative)
Reports To:   President and CEO

 Responsibility and Authority:

Oversee process of preparing submissions for new or modified products to FDA for approval.  Manage process through to approval, including development of regulatory strategies and establishment of test procedures.  Ensure compliance with all U.S. and international regulatory requirements pertaining to product approval, marketing, and labeling. Plan and direct the establishment of quality assurance standards.  Responsible for the application and maintenance of quality standards as they apply to products and services of the company both nationally and internationally.

 Scope of Duties / Job Description:

  • Act as primary liaison with FDA, a Notified Body, and International Regulatory authorities. 
  • Responsible for all MDR and Vigilance reporting to management representative.
  • Review and interpret regulatory rules and ensure that they are communicated through company policies and procedures.
  • Develop regulatory plans and strategies.
  • Organize, prepare and review FDA applications and other regulatory documents, including 510(k)s, Pre-Market Approval Applications, Investigational Device Exemptions, and Medical Device Reports as needed.
  • Organize, prepare, review and maintain technical files for new or modified products.
  • Review and approve Clinical Investigational Plans and Institutional Review Board/Ethics Committee submissions.
  • Review all data prior to submission to FDA and other regulatory agencies.
  • Review all product labeling and marketing materials to ensure compliance with national and international regulatory requirements.
  • Review and approve all changes to manufacturing processes to ensure compliance with QSR and MDD requirements.
  • Establish and implement companywide documentation procedures used in fulfilling QSR and MDD requirements.
  • Hire, train, and manage Quality Assurance.
  • Direct interactions with FDA, State Department of Health and the Notified Body during company inspections.
  • Maintain current knowledge of QSR, MDD, and quality assurance issues.
  • Proactively champion quality assurance issues where applicable in company-wide activities.
  • Establish regular employee training in QSR and MDD regulations.
  • Thoroughly document all issues related to quality assurance, QSR, and MDD compliance.
  • Plan, schedule, and complete projects in a manner consistent with corporate objectives.
  • Regularly make presentations to the Design Review group, Executive Staff, and Board of Directors as required regarding project status.
  • Proactively communicate project status to management.
  • Develop and administer department budgets, schedules, and other administrative functions.

 Working Conditions:

  • No medical conditions preventing access to a controlled environment room.

 Education / Training:

  • BS in life sciences, engineering, or equivalent required, MS preferred.
  • Minimum of seven years of related experience in the medical device industry in addition to a minimum of three years of supervisory experience.

 Other Requirements:

  • Highly developed communications and leadership skills. 
  • Demonstrated teamwork skills (plays well in the sandbox)
  • Demonstrated audit preparation, 13485 certifications and FDA audit success
  • Is able to make the Quality System work for the company and not the other way around
  • Has direct relationship experience within the FDA
  • Has a reputation of getting the job done regardless of the challenges that are present
  • Can work independently within a start up environment and does not need a big department around the

    Position Title:                       Document Control Specialist
    Reports to:                            QA / RA Director
    Department:                         Quality

    PURPOSE OF JOB:          Responsible for assuring that quality documents and records are processed and controlled according to company approved procedures.

     MAJOR DUTIES AND RESPONSIBILITIES:

    • Process (review, track, copy, scan, file, archive and maintain) quality documents and records in electronic and hardcopy format per relevant procedures.
    • Process change control orders, NCMR’s, DHR’s, DCO’s, TPR’s and lot numbers.  Log changes
    • Review, track, file and maintain employee training records.
    • Control engineering lab notebook distribution and retrieval.
    • Manage calibration: Notify PMI of incoming items, log onto system and file upon return to AX
    • Identify and implement improvements to the document control system.
    • Train personnel regarding document format, content, use, control, and the document control system.
    • Audit quality records (e.g. device history records, equipment records) for completeness, accuracy, and conformance to appropriate SOP’s.
    • Collect and enter data into QA databases as needed.
    • Conduct and document process and system audits using written procedures as audit standards.
    • Evaluate problems and make written recommendations for corrective & preventative action.
    • Take actions to ensure that nonconforming practices and procedures are corrected.
    • Order, receive and inspect parts for Stores (temporary)
    • Work with vendors for CER monitoring
    • Process NDA’s (temporary)
    • Process Consulting Agreements (temporary)
    • Support goals and objectives of company

     EDUCATION REQUIREMENTS: Junior College or technical school graduate, High School graduate or equivalent required.  BA preferred

     EXPERIENCE REQUIREMENTS:  Minimum five years related experience in the medical device industry.

     OTHER QUALIFICATIONS:  Intermediate to advanced computer proficiency (MS Word, Excel, and Outlook), excellent communication skills, time management skills, and attention to detail required.  Administrative knowledge of Solidworks, Visio, and Adobe Acrobat preferred.  Ability to thrive in a fast paced start-up environment.  Demonstrated ability to assess, make recommendations and implement changes in order to simplify a company’s current processes.

  • Job Title:          Manufacturing Engineer                       
    FLSA:                Exempt
    Department:    100
    Reports To:      Sr. Director of Operations

    Scope of Duties / Job Description:

     Major Duties and Responsibilities

    • Design efficient line layout and process flows for complex assemblies
    •  Proficient in eliminating NVA
    •  Experience deploying DFT and/or Lean methodologies
    •  Design and develop new methods and processes for the manufacturer of new or existing products
    •    Identify, design, or purchase, and implement manufacturing aids (fixtures, jigs, tools, etcs) to reduce manufacturing costs associated with direct labor, scrap and rework.
    •  Perform DOE-type engineering and optimization studies
    • Perform Process Validation tasks related to new products and processes (IQ, OQ, PQ, PPQ)
    •  Selection of equipment to support manufacturing processes, including scale up of new and prototype processes
    •  Identify product design changes to improve quality and reduce cost
    •  Evaluate processes to identify areas to improve quality, cost efficiency and employee safety
    •  Author test protocols, reports & manufacturing documents related to new processes
    •  Troubleshoot product returns for root cause, identify possible solutions, and test
    •  Interface daily with in-house and contract manufacturing engineering teams to identify/resolve problems and implement solutions to stabilize product.
    •  Key contributor in the design and roll out of new product introduction into hi-volume production
    •  Apply and reinforce Design for Manufacturing (DFM) strategies to address ease of manufacturing, cost and quality goals
    • Knowledge of FDA regulated medical device product manufacturing process; experience with introduction of new products, and development of new manufacturing processes
    • Thorough understanding of FDA, GSR, and cGMP requirements

     Education / Training: 

    • BS in Engineering is prefered, and/or equivalent experience
    •   5+ years in process/manufacturing engineering of medical device products ideally with both, start up and large company experience.

     Other Requirements:  

    •  Expertise in tool, component and fixture design
    •  History of successfully optimizing manufacturing processes
    •   Experience with Class II or Class III Medical Devices required
    •  Proficiency in SolidWorks
    •  Strong documentation skills, familiar with FDA requirements