Careers at CardioFocus

  • QUALITY ASSURANCE SPECIALIST

    Job Title:                   Quality Assurance Specialist

    Department:             Quality Assurance

    Job Reports To:       Quality Manager/Director of Quality

    FLSA:                         Exempt

     
    Essential Duties & Responsibilities::

    • Maintain complaint system including vigilance reportability determination. Investigate complaint returns to attempt to confirm reported complaints. Determine root cause of confirmed complaints, and work with other functions at CardioFocus to determine and implement corrective actions.
    • Support manufacturing activities to continually improve product quality. Develop and implement inspection procedures. Participate in the disposition of non-conforming material and the investigation into root causes and implementation of corrective and preventive actions.
    • Assist in implementing and maintaining the quality management system, including corrective and preventive actions, calibration, preventive maintenance, and internal and external quality audits.
    • Support QA department and the company with internal or supplier Quality System audits.
    • Other activities as directed to support the Company’s quality goals and objectives.

     
    Core Competencies:

    • Must have strong interpersonal skills and the ability to interface well with all employees.
    • Must have excellent organizational skills.
    • Must be thorough and detail oriented.
    • Must have excellent reading, proofreading, editing and technical writing skills and verbal communication skills in the English language.
    • Must be proficient in the use of Microsoft Office.
    • Ability to work within strict deadlines. Requires individual that can accurately and efficiently work on multiple projects.
    • Basic knowledge of statistics and statistical techniques.
    • Basic knowledge of quality planning, data collection, and charting.

     
    Minimum Qualifications:

    • Undergraduate college degree in an engineering discipline preferred, 0-2 years of work experience, or a combination of education and work experience.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • MANUFACTURING ADMINISTRATOR

    Job Title:                   Manufacturing Administrator

    Department:             Operations

    Job Reports To:       Department of Manufacturing

    FLSA:                         Non-Exempt

     

    Position Overview:

    The Manufacturing Administrator supports the day to day administration requirements in an ISO 13485 medical device manufacturing facility.
     
    Essential Duties & Responsibilities::

    • Organize and distribute paperwork to operators, team leads and supervisors relating to device history records (DHRs), Training Records, and manufacturing Deviation copies where applicable.
    • Work with engineers on projects related to labeling updates.
    • Verify procedures used on production floor are on current revision after release of engineering change notices.
    • Print and distribute product labels for accurate tracking of product including catheters, endoscopes, D2O media for 3 different product markets (EU, US and JP).
    • Track manufacturing deviations and ensure associate paperwork is appropriately documented.
    • Review paperwork for completeness based on Good Documentation Practices.
    • Coordinate with operators to complete training through MedTrack Database.
    • Prepare sterilization load paperwork and document accurate product serial numbers of catheters within the load.
    • Complete Epicor transactions (transacting raw materials and finished goods). ERP.
    • File and organize documentation related to job completion including station logs.
    • Create spreadsheets and tables based on needs of production supervisor to organize information.
    • Scribe daily stand-up meetings.

     
    Core Competencies:

    • Positive attitude.
    • Organizational skills.
    • Microsoft Office Suite.
    • Interpersonal skills.

     
    Minimum Qualifications:

    • Administrative experience in a manufacturing environment using ERP or database information systems.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be on their feet and mobile for 8 hours a day, move throughout the facility to accomplish required tasks, visually prepare and analyze data, and work at a computer.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • ENGINEERING TECHNICIAN

    Job Title:                   Engineering Technician

    Department:             Operations

    Job Reports To:       Director of Manufacturing

    FLSA:                         Non-Exempt

     

    Position Overview:

    The Engineering Technician provides day to day technical support in a ISO 13485 medical device clean room manufacturing facility.
     
    Essential Duties & Responsibilities::

    • Process improvement for capacity and yields performance.
    • Basic machining skills for tooling/fixturing creation.
    • Understanding the basic manufacturing process to contribute to overcoming challenges.
    • Using a microscope.

     
    Core Competencies:

    • Solid works.
    • Positive attitude.
    • Organizational skills.
    • Microsoft Office – Word & Excel.
    • Interpersonal skills.

     
    Minimum Qualifications:

    • Experience in a manufacturing environment using engineering technical skills.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be at a desk or on their feet and mobile for 8 to 10 hours a day, move throughout the facility to accomplish required tasks, visually prepare and analyze data, and work at a computer for long periods at a time.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • GLOBAL SERVICE MANAGER

    Job Title:                   Global Service Manager

    Department:             Operations

    Job Reports To:       Vice President – Operations

    FLSA:                         Exempt

     

    Position Overview:

    The Global Service Manager is responsible for staffing and managing a world class service organization to support US and International customers while maximizing customer satisfaction.
     
    Essential Duties & Responsibilities::

    • Maintaining and continuously improving a customer focused global field service strategy to support company growth plans.
    • Supporting new and existing distributors with technical support and service training.
    • Developing, supporting, and monitoring departmental objectives and metrics towards the goal of achieving exceptional customer service.
    • Developing or improve existing processes, W.I.s or SOPs to perform installation, service, maintenance, and modification of CardioFocus equipment.
    • Maintaining global list of console locations through utilization of database systems.
    • Maintaining system DHRs.
    • Installing new consoles, repair or service existing consoles as needed.
    • Developing and managing departmental expenses in accordance with annual budgeting targets.
    • Identifying and driving adoption of Key Performance Indicators as they apply to field service.
    • Training staff as needed to maintain and improve competency.
    • Monitoring spare parts Inventory and replenishment as appropriate.
    • Continuously evaluating MTBF and equipment life expectancy and developing strategies for customer support.
    • Assisting and addressing customer satisfaction issues. Manage customer expectations before and after customer interaction to maximize customer satisfaction.
    • Other projects, assignments, and duties as required.

     
    Core Competencies:

    • Experience building/managing a Service organization with a strong leadership track record and thorough understanding of Service practices.
    • Solid Technical knowledge of Electro-Mechanical systems. Laser experience preferred.
    • Ability to troubleshoot technical issues, respond to emergency service requests, determine root cause and implement corrective actions.
    • Ability to prioritize departmental activities set effective (SMART) goals and objectives in line with overall corporate strategy.
    • Display willingness to make difficult decisions and include appropriate personnel in decision-making process; exhibit sound and accurate judgment.
    • Ability to forge positive relationships and communicate effectively with all levels of management and with all departments.
    • Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.

     
    Minimum Qualifications:

    • Bachelor’s Degree preferably in Engineering or equivalent work experience.
    • Minimum five years of management experience in Medical Device industry.
    • Strong CRM or PM system experience.
    • Familiar with working in a regulated industry.
    • Strong analytical, planning and organizational skills.
    • Must speak and understand English proficiently.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be at a desk or on their feet and mobile for 8 to 10 hours a day, move throughout the facility to accomplish required tasks, visually prepare and analyze data, and work at a computer for long periods at a time. Must have the ability to lift/move/carry for short distances materials weighing up to 25 lbs. No specific vision requirements. International and Domestic travel up to 50% of time is required.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • MANUFACTURING ENGINEER

    Job Title:                   Manufacturing Engineering

    Department:             Operations

    Job Reports To:       Director of Manufacturing

    FLSA:                         Exempt

     

    Position Overview:

    The candidate will be responsible for manufacturing and sustaining engineering for a complex electro-mechanical/ optical medical device that is manufactured in a controlled environment. Efforts will focus on improving and/or developing processes, tooling and fixtures for existing products or new products. Candidate will provide leadership, interface, and support for peers in other departments including Quality, Supply Chain, R&D, and Finance.
     
    Essential Duties & Responsibilities::

    • Work with manager and team members to learn products and their associated manufacturing requirements in order to support manufacturing personnel and processes.
    • Understand the user needs and requirements for existing products and processes and update them as needed to improve quality, reduce cost to manufacture, and address obsolescence and regulatory changes.
    • Lead and participate in cross-functional teams.
    • Provide training, direction and manufacturing support for a team of Manufacturing Group Leaders, Assemblers, Engineers, and Technicians.
    • Work with Manager to assure efforts are in full compliance with company Quality policies, ISO and other relevant regulations, company SOP’s and manufacturing procedures.
    • Prepare quality system documentation such as Engineering Change Notifications, Non-Conforming Material Reports, test protocols and reports, process FMEAs and process maps to support operations and Regulatory submissions.
    • Provide leadership and support for manufacturing, sales and quality regarding complaint resolution, product testing, CAPA investigations, and product documentation reviews (specifically including Manufacturing Procedures).
    • Set up standard and special purpose laboratory equipment to test and evaluate devices at different stages of assembly.
    • Formulate tests, calibrations and procedures to maintain precision accuracy of devices.
    • Observe all safety and security procedures; report and manage potentially unsafe conditions, specifically in and around manufacturing areas.
    • Communicate regularly to Engineering Manager and other stakeholders regarding the status of issues and projects.
    • Additional tasks and responsibilities as assigned.

     
    Core Competencies:

    • Strong knowledge associated with electro-mechanical and optical systems.
    • Strong knowledge of Adhesive and Solvent bonding assembly of polycarbonates.
    • Ability to convert manual assembly processes to semi-automated processes.
    • Strong knowledge of manufacturing processes associated with single use medical devices.
    • Ability to prioritize, plan, and execute work activities efficiently and effectively to meet company, department, and project goals.
    • Demonstrated accuracy and thoroughness; ability to monitor own work to ensure quality.
    • Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.

     
    Minimum Qualifications:

    • Bachelor’s Degree in Electrical, Mechanical or Biomedical Engineering.
    • Five years engineering experience in a medical device manufacturing environment. Catheter experience preferred.
    • Solid knowledge of QSR, ISO 13485, and the MDD is highly desired.
    • Familiarity with LEAN principles preferred.
    • Must have ability to read, understand, and develop SOP’s, engineering drawings, and manufacturing procedures.
    • Candidate must speak and understand English effectively.
    • Excellent communication skills (verbal and written) required.
    • Ability to collect, collate, and present data effectively. Grasp of statistical techniques a plus.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be on their feet and mobile for 8 to 10 hours a day, move throughout the facility to accomplish required tasks, visually prepare and analyze data, work at a computer, and review assemblers’ work using a microscope and/or small tools and fixtures. Ability to lift/move/carry for short distances equipment weighing up to 25 lbs. Specific vision requirements of this job include close vision and ability to adjust focus.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • DIRECTOR, ENGINEERING

    Job Title:                   Director, Engineering

    Department:             Operations

    Job Reports To:       Vice President, Operations

    FLSA:                         Exempt

     

    Position Overview:

    This individual is responsible for staffing and directing Manufacturing Engineering, Field Service and Facility Operations to achieve technical initiatives in support of the business. The successful candidate will be a hands-on leader of professionals, able to provide direction towards all Technical activities, including Sustaining Engineering, Process Development, Process Improvement and Facilities. Interaction with executive leadership in R&D, Sales & Marketing, Quality/Regulatory and Finance will be a regular requirement. Excellent communication and presentation skills are required. Considerable influence with regards to technical direction and process evaluation will be expected and the position will maintain a level of individual contribution.
     
    Essential Duties & Responsibilities::

    • Direction of cross functional and departmental teams to achieve Technical initiatives.
    • Ensures that all initiatives are in full compliance with company Quality policies, ISO and other relevant regulations, company SOP’s and manufacturing procedures.
    • Generates and manages project list and prioritizes based on business needs and ROI analysis.
    • Manages Customer Service Team.
    • Maintains a working knowledge of new technologies which may improve operations and develops recommendations accordingly.
    • Working with V.P Operations to identify and justify resource requirements in order to successfully support overall Operations and Company goals.
    • Conferring with R&D as required to support new product initiatives.
    • Effectively manages department budget.
    • Forecasts operating costs of department and develops department budget.
    • Advises management of new developments which may affect profit, schedule, costs, customer relations, and/or inter-departmental relations.
    • Working with functional departments to collect and analyze relevant process data. Promote using this data to identify, analyze and implement continuous improvements.
    • Interfacing with department leaders to ensure all Facility requirements are met, including Maintenance, seating and lease management matters.
    • Maintains a working knowledge of safety policies and regulations.
    • Other tasks and responsibilities as assigned.

     
    Core Competencies:

    • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
    • Strives to continuously build knowledge and skills; Shares expertise with others.
    • Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance.
    • Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives.
    • Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities.
    • Includes staff in planning, decision-making, facilitating and process improvement; Makes self available to staff; Provides regular performance feedback; Develops subordinates’ skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.
    • Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
    • Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles.
    • Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.

     
    Minimum Qualifications:

    • Bachelor’s Degree in an Engineering discipline. Advanced degree in Engineering or Management is a plus.
    • 7 to 10 years Engineering management experience. Minimum of three years in a regulated medical device manufacturing environment.
    • Solid knowledge of QSR, ISO 13485 is required.
    • Familiarity with Lean principles is required. Green Belt or higher is preferred.
    • Understanding of COGS and Manufacturing metrics is required.
    • Excellent verbal and written communication skills.
    • Ability to organize and present data effectively to all levels of the organization.
    • Intermediate or better software skills including PLM systems and Office products.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be on their feet and mobile for extended periods. Ability to lift/move/carry for short distances equipment weighing up to 25 lbs.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • FINAL CATHETER/SUB ASSEMBLY MANUFACTURING TEAM LEAD

    Job Title:                   Final Catheter/Sub Assembly Manufacturing Team Lead

    Department:             Operations

    Job Reports To:       Manufacturing Supervisor

    FLSA:                         Non-Exempt

     

    Position Overview:

    The Final Catheter/Sub Assembly Manufacturing Team Lead will lead a group of assembly associates in a controlled manufacturing environment that assemble, test, and evaluate complex medical devices in conformance to established standards. The position requires taking team to the next level and assisting in creating increased capacity and quality through lean manufacturing practices.
     
    Essential Duties & Responsibilities::

    • Provides daily activity leadership for group to accomplish production and quality requirements.
    • Reviews paperwork, training records and equipment being used in production for adherence to compliance requirements.
    • Works with other Manufacturing leaders to create plans in overcoming challenges and fosters a can do team work environment.

     
    Core Competencies:

    • Positive attitude.
    • Leadership and conflict resolution skills are a must.
    • Experience working in Medical Device clean room environments.
    • Lean Manufacturing experience.
    • Attendance/Punctuality – Is consistently at work and on time.
    • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance.

     
    Minimum Qualifications:

    • Education and/or Experience – Two year degree from college or technical school; or 5+years manufacturing related experience and/or training; or equivalent combination of education and experience.
    • Language Skills – Ability to read and understand SOP’s and manufacturing procedures. Ability to print and speak English. Ability to read and understand simple procedures, instructions and/or notebook entries.
    • Computer Skills – Basic, word processing, spreadsheet or database entry. Ability to learn operations or business software when properly trained.

     
    Physical Demands:

    While performing the duties of this Job, the employee is regularly required to stand and walk in the production area.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • LESION GENERATOR/BALLOON MANUFACTURING TEAM LEAD

    Job Title:                   Lesion Generator/Balloon Manufacturing Team Lead

    Department:             Operations

    Job Reports To:       Manufacturing Supervisor

    FLSA:                         Non-Exempt

     

    Position Overview:

    The Lesion Generator/Balloon Manufacturing Team Lead will lead a group of assembly associates in a controlled manufacturing environment that assemble, test, and evaluate complex medical devices in conformance to established standards. The position requires taking team to the next level and assisting in creating increased capacity and quality through lean manufacturing practices.
     
    Essential Duties & Responsibilities::

    • Provides daily activity leadership for group to accomplish production and quality requirements.
    • Reviews paperwork, training records and equipment being used in production for adherence to compliance requirements.
    • Works with other Manufacturing leaders to create plans in overcoming challenges and fosters a can do team work environment.

     
    Core Competencies:

    • Positive attitude.
    • Leadership and conflict resolution skills are a must.
    • Experience working in Medical Device clean room environments.
    • Lean Manufacturing experience.
    • Attendance/Punctuality – Is consistently at work and on time.
    • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance.

     
    Minimum Qualifications:

    • Education and/or Experience – Two year degree from college or technical school; or 5+years manufacturing related experience and/or training; or equivalent combination of education and experience.
    • Language Skills – Ability to read and understand SOP’s and manufacturing procedures. Ability to print and speak English. Ability to read and understand simple procedures, instructions and/or notebook entries.
    • Computer Skills – Basic, word processing, spreadsheet or database entry. Ability to learn operations or business software when properly trained.

     
    Physical Demands:

    While performing the duties of this Job, the employee is regularly required to stand and walk in the production area.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • SENIOR QUALITY INSPECTOR

    Job Title:                   Senior Quality Inspector

    Department:             Quality

    Job Reports To:       Product Quality Manager or Quality Manager or Director, QA and Regulatory Compliance

    FLSA:                         Non-Exempt

     

    Position Overview:

    Quality Inspector will work in a controlled environment and will inspect medical devices.

    • Follows production drawings and procedures, or receives verbal instructions regarding duties to be performed.
    • Be able to follow and revise Quality and Manufacturing procedures for inspection purposes.
    • Documents and informs other of any material issues for prompt corrective action.
    • Positions and aligns parts in specified relationship to each other in a jig, fixture, or other holding device.
    • Inspect incoming materials, components, sub-assemblies and final products.
    • Performs other QA related functions collaboratively with Manufacturing such as assisting with DHR review, equipment calibration and PMs.
    • Performs go/not-go testing and inspection to ensure parts and assemblies meet production specifications and standards.
    • Interact with other Quality Associates and other department members.
    • Communicate and mentor junior QA and QI members in cleanroom.
    • Assists QA with Document Control and training records as needed or directed.

     
    Minimum Qualifications::

    • Education and/or Experience – Two to four years related experience and/or training; or equivalent combination of education and experience.
    • Two years’ experience working in Quality Assurance/ Quality Control preferred.
    • Minimum of 2-4 year experience working under s controlled environment performing Quality Control or Quality Assurance Duties.
    • Language Skills – Ability to read and understand SOP’s and manufacturing procedures. Ability to print and speak simple English sentences.
    • Mathematical Skills – Basic.
    • Reasoning Ability – Ability to apply good common sense to carry out multi-step written or verbal instructions.
    • Computer Skills – Basic.

     
    Skills and Abilities Required:

    • Judgment – Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
    • Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Develops realistic action plans.
    • Professionalism – Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
    • Work Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
    • Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions ; Uses equipment and materials properly.
    • Attendance/Punctuality – Is consistently at work and on time.
    • Dependability – Follows instructions, responds to management direction; takes responsibility for own actions. Completes tasks in the agreed upon time.
    • Initiative – Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities. Looks for and takes advantage of opportunities; Asks for and offers help when needed.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • QUALITY INSPECTOR

    Job Title:                   Quality Inspector

    Department:             Quality

    Job Reports To:       Quality Manager/Director of Quality

    FLSA:                         Non-Exempt

     

    Position Overview:

    • Follows production drawings and procedures, or receives verbal instructions regarding duties to be performed.
    • Be able to follow and revise Quality and Manufacturing procedures for inspection purposes.
    • Documents and informs other of any material issues for prompt corrective action.
    • Positions and aligns parts in specified relationship to each other in a jig, fixture, or other holding device.
    • Inspect incoming materials, components, sub-assemblies and final products.
    • Performs other QA related functions collaboratively with Manufacturing such as assisting with DHR review, equipment calibration and PMs.
    • Performs go/not-go testing and inspection to ensure parts and assemblies meet production specifications and standards.
    • Interact with other Quality Associates and other department members.
    • Communicate and distribute work to other Quality members in cleanroom.
    • Train other junior Quality Associates as needed.
    • Assists QA with Document Control and training records as needed.

     
    Minimum Qualifications::

    Requires at a minimum a BS in a science or engineering discipline with 2 or more years of medical device regulatory affairs; or an equivalent combination of education and experience.

    • Education and/or Experience – Zero to one year related experience and/or training; or equivalent combination of education and experience.
    • Two years’ experience working in Quality Assurance/ Quality Control preferred.
    • Minimum of 0-1 year experience working under s controlled environment performing Quality Control or Quality Assurance Duties.
    • Language Skills – Ability to read and understand SOP’s and manufacturing procedures. Ability to print and speak simple English sentences.
    • Mathematical Skills – Basic.
    • Reasoning Ability – Ability to apply good common sense to carry out multi-step written or verbal instructions.
    • Computer Skills – Basic.

     
    Skills and Abilities Required:

    • Judgment – Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
    • Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Develops realistic action plans.
    • Professionalism – Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
    • Work Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
    • Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions ; Uses equipment and materials properly.
    • Attendance/Punctuality – Is consistently at work and on time.
    • Dependability – Follows instructions, responds to management direction; takes responsibility for own actions. Completes tasks in the agreed upon time.
    • Initiative – Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities. Looks for and takes advantage of opportunities; Asks for and offers help when needed.
    • Innovation – Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Presents ideas and information in an effective manner.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • FIELD CLINICAL SPECIALIST

    Job Title:                   Field Clinical Specialist

    Department:             Sales / Field Support

    Job Reports To:       Managing Director

    FLSA:                         Exempt

     

    Scope:

    Working with the US Sales & Marketing team in a collaborative and cross-functional setting, the Field Clinical Specialist will participate with the US Sales & Marketing team in the field support and education using the Company’s unique Endoscopic Ablation System in the treatment of patients with atrial fibrillation (AF).

    Responsibilities:

    • Support US physicians and hospital staff when using the HeartLight Ablation system to treat AF according to industry standards and the product IFU
    • Support new site launches of the HeartLight catheter and console for ablation of atrial fibrillation in the US
    • Support communication with US Territory Managers and the Marketing team
    • Support selection of new centers
    • Support site personnel training on the use of the Company’s products according to the industry standards and the product IFU
    • Support site communication for device shipments and cases
    • Verify proper device shipment, accountability and disposition
    • Provide product feedback when necessary, including implant case report forms (CRFs) and complaint handling

     
    Requirements:

    • Four year engineering degree preferred
    • At least 1-2 years of hospital experience, ideally in the EP lab conducting ablations
    • At least 1 years working for a medical device EP company supporting clinical cases of AF pulmonary vein isolation (PVI) ablation or similar experience
    • Prior positive relationships with AF ablation centers in the US preferred
    • Ability to work in fast paced dynamic setting
    • Excellent interpersonal, organizational, and critical thinking skills; able to interface with leading thought leaders in the field of AF ablation
    • Positive, self-motivated, creative, detail oriented team player
    • Travel: Up to 70%
    • Able to withstand physical requirements of supporting AF cases while wearing lead
    • Able to withstand physical requirements of travel

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com