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SynCardia Systems, Inc.

Careers at SynCardia

SynCardia Systems, LLC is a fast-paced, rapidly growing company committed to providing Bridge to Life technologies for patients dying from heart failure.

In addition to manufacturing the world’s only FDA, Health Canada and CE approved Total Artificial Heart, SynCardia is also developing a smaller 50cc Total Artificial Heart and new drivers for powering the SynCardia temporary Total Artificial Heart.

SynCardia is based in Tucson, Arizona, a city that enjoys more than 300 days of sunshine annually. The high-desert climate and surrounding mountains provide a perfect playground for year-round outdoor activities such as golf, hiking, biking and even winter skiing (just 30 miles away on Mt. Lemmon). With Tucson’s unique blend of Southwestern, Mexican and Native American cultures, residents can enjoy everything from rodeos to symphonies.

We are seeking dedicated, talented overachievers for career opportunities as we expand our Bridge to Life technologies that make a difference in people’s lives all over the world.

Current Career Opportunities:

Sales Coordinator

Department: Sales
Reports to: VP of Sales
Supervises: N/A
Exempt/Nonexempt: Exempt

Essential Duties and Responsibilities

  • Respond to prospective customer and distributor inquiries
  • Generate and distribute start-up and product quotes
  • Manage hospital contract execution and renewals
  • Manage set up of SynCardia as a vendor at new hospitals
  • Generate and maintain distributor agreements
  • Implement and manage CRM
  • Assist with trade show efforts and lead follow-up
  • Identify data and strategies to guide sales efforts
  • Create, distribute and maintain resources to support sales efforts
  • Work cross-functionally/departmentally to execute sales initiatives
  • Sales point of contact for inter-departmental communication (with Clinical Support, Clinical Research, Certification, Finance, Logistics, Marketing, Executive Management, etc.)
  • Assist Sales/Clinical Support/Certification departments as needed

Position Requirements

  • Skills and abilities
    • Excellent communication skills
    • Excellent writing skills
    • Strong organizational skills
    • Detail oriented
    • Ability to handle multiple tasks simultaneously
    • Team player
  • Education, experience and training
    • Bachelor’s degree or 5 or more years of sales experience
    • Computer application skills – experience in Microsoft ACT, Outlook, Word, and Excel and/or salesforce.com
    • Strategic business communication
  • Working environment
    • Work station area: Office
    • Special factors in the work area: None
    • The working environment is indoors and seasonally heated and cooled with minimal noise levels.
    • The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
    • The position requires the ability to communicate in person, telephonically and via email.

To apply, please email cover letter and resume to humanresources@syncardia.com

Senior Quality Engineer

Department: Quality
Reports to: Director of Quality
Supervises: N/A
Exempt/Nonexempt: Exempt

Essential Duties and Responsibilities

  • Implement cost of quality concepts, including quality cost categories, data collection, reporting, etc., for manufacturing, engineering and quality
  • Provide training and direction, as required, to other individuals in quality regarding conduct of product inspection, documentation reviews or incoming inspection methodologies and evaluations
  • Review and approve inspections of components and subassemblies as required and document compliance to approved specifications and procedures
  • Coordinate, review and approve laboratory testing of raw materials, assemblies, finished goods and environmental conditions
  • Devise sampling procedures and designs and develop forms and instructions for recording, evaluating and reporting quality and reliability data
  • Schedule and conduct Quality System audits of material and service suppliers
  • Coordinate, oversee and approve sterilization validation and environmental monitoring activities
  • Ensure systematic planning and controlling of product and process quality in manufacturing
  • Support a systematic program for quality problem-solving and continuous improvement in manufacturing
  • Quality System support

Position Requirements

  • Skills and abilities
    • Excellent communication skills
    • Excellent writing skills
    • Strong organizational skills
    • Detail oriented
    • Ability to handle multiple tasks simultaneously
    • Team player
  • Education, experience and training
    • Bachelor’s or master’s degree in an engineering/biological science discipline or equivalent
    • ASQ Quality Engineering Certification or equivalent is desired
    • Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems and professional ethics
    • Thorough understanding of a Quality System and its development, documentation and implementation with respect to domestic and international standards and requirements
    • Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results and follow-up
    • Ability to develop and implement quality programs, including tracking, analyzing, reporting and problem-solving
    • Ability to plan, control and assure product and process quality in accordance with quality principles. which include panning processes, material control, acceptance sampling and measurement systems
    • Thorough knowledge of statistical analysis, reliability, maintainability and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting
    • Thorough understanding of problem-solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions and how to overcome barriers to quality improvements
    • Thorough understanding regulatory standards applicable to Medical Devices, such as, MDD, AIMDD, MDR, ISO 13485, IEC standards, (60601), 21 CFR 820, 21 CFR 803 and 806, SOR/98-282, ISO 10993 and various MEDDEV and ASTM standards
    • Ability to acquire and analyze manufacturing data using appropriate standard quantitative and statistical methods across a spectrum of business environments to facilitate process analysis and improvement
    • Minimum of five years of experience in a regulated industry or equivalent; preferably Class 3 implantable Medical Devices
  • Working environment
    • Work station area: Office, laboratory and controlled environment manufacturing area
    • Special factors in the work area: None
    • The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
    • The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
    • The position requires the ability to communicate in person, telephonically and via email.

To apply, please email cover letter and resume to humanresources@syncardia.com

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