Careers

Cleveland Heart Corporation is a fast-growth company that is revolutionizing medical technology. We are headquartered in the heart of Cleveland, Ohio and have offices in Charlotte, North Carolina and Miami, Florida.

Cleveland Heart is interested in outstanding professionals with the vision and drive to work in a highly entrepreneurial environment and contribute to the company's success as a team.

Interested candidates should submit their resumes via email.

Please review our current job listings to the right.

 

Clinical Research Associate
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Purpose of Job:

This position is responsible for supporting the activities of the clinical research group.

Major Duties and Primary Responsibilities
  • Supports clinical team in tracking, organizing, filing and maintaining all study-related documents in accordance with applicable regulations (i.e., ISO 14155, Federal Regulations, GCP).
  • Assists clinical team members in handling data queries, study invoice and payment, enrollment tracking, record reconciliation with site documentation.
  • Sets up and manages process to track and report critical study information such as enrollment, IRB/EC approval status, appropriate training of site personnel, device usage and payment information as needed.
  • Ensures proper product supply, accountability, and storage during assigned clinical studies by processing orders, maintaining inventory information, and maintaining device accountability tracking information.
  • Works with the Clinical Trial Managers to ensure that sites receive the study documentation necessary to secure IRB/EC approval and ensures that sites have the study materials needed for the conduct of the study (e.g., regulatory binder, CRFs, etc.).
  • Works with the Clinical Trial Managers to ensure timely collection of study documentation for clinical sites.
  • Processes case report forms for data entry and/or for timely review and proper handling of adverse event reports in accordance with company procedures and regulatory requirements.
  • Reconciles data queries and data clarifications with sites.
  • Assists the Safety Coordinator/Monitor with collection and compilation of materials for the Clinical Events Committee and the Data Safety and Monitoring Board.
  • Assists in various projects, as assigned.


Job Requirements:

Bachelor's Degree (or equivalent combination of education and work experience) required, and a minimum of 3 years industry experience, including at least 1 year as a CRA. Knowledge of and competence in application of CFRs, GCPs, ISO, and ICH Guidelines. Demonstrated proficiency in required software and computer skills. Ability to independently set and manage multiple priorities. Ability to apply, or assist others in applying, the appropriate level of detail to achieve project goals in a timely manner with attention to applicable regulations. Operates effectively as a team member or leader with an understanding of team dynamics; demonstrates ability to guide others in effectively executing work processes. Excellent oral and written communication skills.

Interested candidates should submit their resumes via email.

Clinical Specialist
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Purpose of Job:

Provide technical, educational and clinical research support to meet training and enrollment objectives in clinical trials.

Major Duties and Primary Responsibilities:
  • Supports the resource planning, execution, and documentation of all clinical evaluations conducted to support, regulatory filings or marketing initiatives.
  • Represents Cleveland Heart during pulse generator placement procedures ensuring that clinical research protocol is followed and documents any protocol deviations.
  • Provides support with clinical investigations in assigned institutions. Ensures completion of necessary documentation.
  • Educates and trains physicians, hospital personnel and office staff on technical matters relating to our products through conducting and/or coordinating: one-on-one training sessions and in-service education programs
  • Provides training and resources for hospital staff to enable them to conduct training for their personnel (train the trainer).
  • Serves as effective Cleveland Heart representative to physicians and support staff regarding Cleveland Heart clinical trial.
  • Extensive travel 50-75% primarily in the US with the possibility to travel outside the US.
  • Supports oral and written presentations of clinical results by study investigators.
  • Attends scientific sessions and symposia, and summarize relevant posters and presentations.
  • Demonstrates strong interpersonal skills and ability to independently confront issues for a win-win outcome.
  • Provides weekly project updates on critical study information including enrollment, site status, CRF and DCF status, and adverse events.
  • Train CRO staff in accordance with Cleveland Heart procedures and implementation of the study protocol.


Job Requirements:

Bachelor's Degree in nursing, cardiovascular, or technical discipline (or equivalent). Demonstrated proficiency in required software and computer skills. Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences. Strong team leadership experience and motivational skills. Strong clinical skills and in-depth knowledge of the field of interventional cardiology. Ability to work with many different customers from varying backgrounds. Proven track record with technical training assignments.

Interested candidates should submit their resumes via email.

Director, Analytical Chemistry
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Purpose of Job:

Provide strategic and tactical direction with regard to analytical chemistry and drug formulation to assure that the company is in compliance with US and international regulatory requirements and will be successful in securing regulatory approvals on a timely basis.

Major Duties and Primary Responsibilities:
  • Assure awareness of and compliance with all US (e.g., FDA Guidelines, cGMP) and international regulatory approval (e.g. ICH Guidelines, EMEA Guidelines) and compliance requirements (cGMP and Quality System) as they relate to analytical testing and drug formulation.
  • Assure that the analytical chemistry groups are adequately staffed to support the method development, method validation, stability testing, drug formulation, and release testing activities.
  • Assure that the analytical chemistry groups have adequate facilities for analytical testing and drug formulation.
  • Assure that the analytical chemistry groups have adequate equipment and that the equipment is maintained in accordance with normal operational and Quality System requirements.
  • Secure and maintain the confidence of management regarding awareness of and compliance with all US and international regulatory approval and compliance requirements, accuracy and robustness of analytical methods, competence of analytical staff, and accuracy of test results and test reports generated by analytical chemistry.
  • Assure that the company establishes and maintains good relationships with reputable outside laboratories needed to perform activities that cannot practically be done by the company.
  • Draft applicable portions of regulatory submissions (e.g., CMC section for FDA, CTD for CE Design Dossier, responses to questions).
  • Participate in third-party audits (FDA, Notified Body), as required, involving assessment of compliance with cGMP and Quality System requirements.
  • Provide strategic and tactical leadership and direction in solving analytical chemistry and drug formulation problems.


Job Requirements:

Doctoral Degree in Chemistry and a minimum of 10 years of increasingly responsible industry experience (including a minimum of 7 years' experience in pharmaceutical development or drug delivery), or equivalent combination of education and experience. Extensive knowledge of CMC requirements; has written CMC sections for NDA that has received approval. Knowledge of and competence in application of CFRs (210/211 and 820), and ICH Guidelines; analytical organization for which candidate was responsible has passed cGMP inspections. Advanced computer skills specifically in Microsoft Word, Excel and Adobe Acrobat. Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences. Strong team leadership experience and motivational skills. Success with gaining consensus from multidisciplinary teams.

Interested candidates should submit their resumes via email.

International Marketing Manager
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Purpose of Job:

Support international marketing and sales efforts along with distributor relationships.

Major Duties and Primary Responsibilities:
  • Create sales forecasts and product launch plans.
  • Work with Research and Development to determine proper product mix and potential new product needs.
  • Prepare launch and training materials.
  • Have the ability to work with both technical product/design and also clinical trial data.
  • Possess both technical and clinical aptitude in order to facilitate the creation of technical materials, product brochures, clinical trial summaries and training materials.
  • This candidate should also be able to communicate effectively, champion ideas, lead projects, and present in front of a group.


Job Requirements:

BS in Business or related field and 5-7 years of medical device marketing and/or product management. Previous experience in cardiovascular or interventional vascular devices is preferred. Experience in marketing and selling to international markets is a must.

Interested candidates should submit their resumes via email.

Project Coordinator
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Purpose of Job:

Project Coordinator will provide administrative support and overall project coordination for various functional groups.

This role interacts with all levels in the organization, providing the following support:
  • Administrative support (travel arrangements, coordination and planning of meetings, meeting minutes, order supplies and maintain copy/fax area)
  • Development and formatting of documents and presentations
  • manage small scale projects
  • This person must be able to work independently in a fast-paced environment, have great interpersonal skills and ability to interact and communicate professionally with all levels of upper management, suppliers, vendors, and business partners.


Job Requirements:

High school diploma (AA degree strongly preferred or equivalent of at least 1 year of advanced administrative education), and a minimum of 5 years of administrative support experience. Strong administrative skills are required. Excellent verbal and written communications skills are required. Intermediate arithmetic skill and ability to use automated office equipment and maintain written records.

Must have strong computer skills working with Microsoft office programs Word, Excel, PowerPoint, and Outlook. Experience with MS Project is a plus.

Interested candidates should submit their resumes via email.

Regulatory Affairs Manager
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Purpose of Job:

Increase the bandwidth of the Regulatory Affairs department to aid the group in meeting the corporate objectives of Cleveland Heart. This position will support these objectives by assisting in product development teams, performing product registrations, and assuring regulatory compliance.

Major Duties and Primary Responsibilities:
  • Representing Regulatory Affairs on and providing regulatory guidance to project teams regarding: designing, developing, evaluating and commercializing medical devices.
  • Coordinating, compiling, submitting, and processing approval submissions for clinical evaluation or commercialization.
  • Compiling, submitting, and processing approval submissions for export approval/certification.
  • Compiling and submitting device experience reports required to be submitted in accordance with FDA Medical Device Reporting System, the EU Device Vigilance System, and the reporting system of any other applicable venue.
  • Participating in third party audits (FDA, State of California, Notified Body) of the Quality Management System, and assisting with coordinating, compiling, and submitting responses to any observations made during those audits.
  • Review and approval of documentation for regulatory compliance.
  • Support the resource planning, development, execution, and documentation of all regulatory filings or marketing initiatives.
  • Perform audits / reviews.
  • Support oral and written presentations of clinical results by study investigators.
  • Attend scientific sessions and symposia, and summarize relevant posters and presentations.
  • Demonstrate strong interpersonal skills and ability to independently confront issues for a win-win outcome.


Job Requirements:

Bachelor's Degree and a minimum of 5 years of increasingly responsible industry experience (including a minimum of 3 years' experience in pharmaceutical development or drug delivery), or equivalent combination of education and experience.

Extensive knowledge of CMC requirements. Knowledge of and competence in application of CFRs (210/211 and 820), and ICH Guidelines. Advanced computer skills specifically in Microsoft Word, Excel and Adobe Acrobat. Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences. Strong team leadership experience and motivational skills.

Interested candidates should submit their resumes via email.

Sr. Research and Development Engineer
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Major Duties and Primary Responsibilities:
  • Design and develop highly automated precision mechanisms for processing vascular drug delivery technologies.
  • Design micropositioning automation machinery with machine vision guidance.
  • Design and test automated machines for laser cutting and welding microparts.
  • Design and test precision automated optical inspection equipment.
  • Design and analyze mechanisms and components using Solidworks, AutoCAD, ProE, Cosmos and Algor software.


Job Requirements:

MS in Engineering. Three years in the job offered or three years as a Mechanical Engineer. Must have experience in 1) machine vision and robotics, 2) high-speed precision mechanism design, 3) laser processing in microfabrication, and 4) Solidworks, AutoCAD, ProE, and Cosmos.

Interested candidates should submit their resumes via email.

Project Development Engineer
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Purpose of Job:

Use engineering skills to develop new products that will position Cleveland Heart as a company that is on the forefront of the interventional industry.

Major Duties and Primary Responsibilities:
  • Apply materials and material mechanics background, as well as input from others, to develop new and innovative pulse generator designs.
  • Take ownership of and drive the full pulse generator development cycle, from design concept and raw material specification to 3-D Computer Rendering to Finite Element Analysis to Laser Cutting to Polish. This also includes input on raw material specification.
  • Establish in-vitro test methods which will allow the ability to move through pulse generator prototyping rapidly.
  • Establish in-vitro and computer modeling test methods which mimic in-vivo parameters for pulse generator evaluation.
  • With input from all departments, write and execute in-vitro protocols for product performance, reliability and quality characteristics.
  • Monitor R&D pulse generator manufacturing assuring a timely finish and the highest quality possible.
  • Aid in finalizing the product specifications for current and future products.
  • Assist in developing new, and/or modify existing, processes and tooling to increase efficiencies and yields in pulse generator manufacturing.
  • Continuously study the industry for possible development opportunitie.s
  • Ensure that current platform products have all regulatory filing in-vitro and clinical trials requirements completed


Job Requirements:

Bachelor's degree in Mechanical Engineering, Metallurgy, Materials Science or related field is required, and an MS is preferred. 2 years of industry experience specifically in pulse generator design/FEA is also preferred. Good written and verbal communication skills a must.

Interested candidates should submit their resumes via email.

Supervisor, Analytical Research and Development
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Purpose of Job:

A supervisor is a chemist or scientist who has demonstrated technical mastery of laboratory analytical techniques, has good problem-solving skills and has sufficient interpersonal skills to lead a front-line group. He/She monitors day-to-day laboratory regulatory compliance, method and instrument performance, and leads or implements the development of analytical methods and investigations. The supervisor distributes and schedules work assignments in support of project activities. He/She assists the Manager in planning, staffing, budgeting, and other administrative tasks as required.

Experience in HPLC of active pharmaceutical ingredients (content and purity) and polymer characterization (thermal analysis (TGA and DSC) and gel permeation chromatography (GPC)) preferred. Experience in characterization of controlled release formulations including solubility, release kinetics, and stability.

The Supervisor participates in intra-company technical and administrative interactions and is responsible for assuring that his/her group is represented at project meetings when appropriate.

Major Duties and Primary Responsibilities:
  • Assure that reports of analyses, Analytical Methods, method validation reports, method transfer reports and other technical reports are accurate, complete, regulatory compliant, and conform to all relevant SOPs.
  • Formulation & drug stability studies: plan, prepare, manage, and report
  • Distribute work assignments.
  • Participate in method development, validation, and transfer.
  • Ensure appropriate regulatory compliance in all relevant laboratory activities.
  • Participate in the various employee support systems such as reviews, interviews, and disciplinary actions.
  • Participate in or lead various elements of laboratory operations such as calibration, maintenance, housekeeping, and stocking of supplies.
  • Train analysts in Analytical Methods and relevant procedures.


Job Requirements:

Bachelor's degree in chemistry, Pharmacy, Biochemistry or Engineering. At least 5 years of increasingly responsible experience in Pharmaceutical Analysis and formulation, in a cGMP regulatory environment, or equivalent, in an R&D setting.

At least 2 years' direct management responsibilities of technicians and/or entry-level Chemists.

Interested candidates should submit their resumes via email.