Careers at CardioFocus

  • 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

  • QUALITY SUPERVISOR

    Job Title:                   Quality Supervisor

    Department:             Quality Assurance

    Job Reports To:       Quality Manager / Director of Quality & Regulatory Compliance

    FLSA:                         Exempt

     

    Position Overview:

    The Quality Supervisor will work in a controlled environment and will provide leadership to the Quality Inspectors over multiple shifts. Directs, coordinates, and evaluates the activities of these associates, including incoming, in-process, and final packaging inspections. This role oversees Quality on the production floor and ensures business, Quality, and compliance goals are met in full compliance with all regulatory requirements.
     
    Essential Duties & Responsibilities::

    • Conducts or coordinates training of Quality Inspectors to ensure personnel have training to required procedures.
    • Sets daily priorities to Quality Inspectors. Coordinates the activities of the group to ensures production goals are met.
    • Provides feedback to management on individual performance of Quality Inspectors.
    • Be able to follow and revise Quality and Manufacturing procedures for inspection purposes.
    • Identifies and reports any safety, Quality, and/or compliance concern and takes immediate corrective action or escalation, as required.
    • Work with process owners to drive Quality in Manufacturing. Support a state of continuous inspection readiness.
    • Identify opportunities for process improvements.
    • Review and approve Quality records.
    • Support investigations for nonconformances, CAPAs, and containment activities.
    • Inspect incoming materials, components, sub-assemblies, and final products, as required.
    • Supports internal and external audits, as required.

     
    Core Competencies:

    The above information (essential duties and responsibilities) 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.
     
    Minimum Qualifications:

    • Minimum 1 year of experience in a leadership position.
    • 2 – 3 years of regulated industry experience (e.g., medical devices, pharmaceutical) required, Quality Assurance preferred.
    • Education and/or Experience – minimum two year degree from college or technical school; or 5+ years Quality related experience and/or training; or equivalent combination of education and experience.
    • Excellent interpersonal, communication, organizational, and strong collaboration skills with great attention to detail.
    • Experience prioritizing conflicting demands in a fast-paced environment.
    • Proficient in English language

     
    Physical Demands:

    Normal day to day responsibilities in a production cleanroom and office environment with routine sitting and standing.

     
    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

  • SENIOR CLINICAL RESEARCH ASSOCIATE

    Job Title:                  Senior Clinical Research Associate

    Department:             Clinical Affairs

    Job Reports To:       Senior Director of Clinical Affairs

    FLSA:                         Exempt

    Scope:

    Working with the Clinical Affairs team in a collaborative and cross functional setting, the Senior Clinical Research Associate will participate as a clinical team member in the management and execution of a Phase IV cardiovascular medical device trial.

    Responsibilities:

    • Provide overall clinical site management from start-up to close-out
    • Serve as liaison between sponsor and site Investigators and Study Coordinators regarding protocol questions, queries, and enrollment
    • Responsible for site communication and instruction on clinical processes
    • Maintain audit-ready Trial Master File via regulatory document collection, review, and tracking
    • Conduct remote (on sites as needed) Site Initiation Visits, Interim Monitoring Visits and Close-out Visits according to Monitoring Plan and Data Management Plan; activities to include source document verification, electronic CRF review, regulatory document review, and assessment of protocol and regulatory compliance
    • Complete clinical site status reports and monitoring reports; provide ongoing status updates to management
    • Facilitate clinical site contract and budget process
    • Develop clinical trial documents and materials
    • Interface with project team, data management CRO
    • Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA guidelines, and GCP Guidelines

     
    Requirements:

    • BS or higher in biology, health, medical or clinical sciences (e.g., Physiology or Nursing)
    • 5+ years clinical research experience in a medical device (preferred) or CRO setting. Monitoring experience required, including two or more years of independent monitoring
    • Previous experience in a cardiovascular clinical trial preferred
    • Thorough understanding of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trials
    • Experience with Electronic Data Capture (EDC) systems
    • Solid computer skills (Microsoft Word, Outlook, Excel, and PowerPoint)
    • Ability to work in fast paced, dynamic setting
    • Excellent interpersonal, organizational, and critical thinking skills
    • Strong written, verbal, and presentation skills
    • Positive, self-motivated, creative, detail- and solutions-oriented with the ability to work independently as well as collaboratively in a team environment
    • Travel: currently 0%

     
    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

  • CLINICAL RESEARCH ASSOCIATE

    Job Title:                  Clinical Research Associate

    Department:             Clinical Affairs

    Job Reports To:       Senior Director of Clinical Affairs

    FLSA:                         Exempt                

    Scope:

    Working with the Clinical Affairs team in a collaborative and cross functional setting, the Clinical Research Associate will participate as a clinical team member in the management and execution of a Phase IV cardiovascular medical device trial.

    Responsibilities:

    • Provide overall clinical site management from start-up to close-out
    • Serve as liaison between sponsor and site Investigators and Study Coordinators regarding protocol questions, queries, and enrollment
    • Responsible for site communication and instruction on clinical processes
    • Maintain audit-ready Trial Master File via regulatory document collection, review, and tracking
    • Conduct remote (on-site as needed) Site Initiation Visits, Interim Monitoring Visits and Close-out Visits according to Monitoring Plan and Data Management Plan; activities to include source document verification, electronic CRF review, regulatory document review, and assessment of protocol and regulatory compliance
    • Complete clinical site status reports and monitoring reports; provide ongoing status updates to management
    • Develop clinical trial documents and materials
    • Interface with project team, data management CRO
    • Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA guidelines, and GCP Guidelines

     
    Requirements:

    • BS in biology, health, medical or clinical sciences (e.g., Physiology or Nursing)
    • 3+ years clinical research experience in a medical device (preferred) or CRO setting. Monitoring experience required, including one or more years of independent monitoring
    • Previous experience in a cardiovascular clinical trial preferred
    • Working knowledge of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trials
    • Experience with Electronic Data Capture (EDC) systems
    • Solid computer skills (Microsoft Word, Outlook, Excel, and PowerPoint)
    • Ability to prioritize tasks in fast paced, dynamic setting
    • Excellent interpersonal, organizational, and critical thinking skills
    • Strong written, verbal, and presentation skills
    • Positive, self-motivated, creative, detail-oriented team player
    • Travel: currently 0%

     
    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