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Careers

We’re currently hiring.  Scroll through the Current Job Opportunities for Details.

Join our team!

TandemLife is seeking passionate, hard-working candidates for positions throughout the company, from producing our products to selling and supporting them in hospitals worldwide.  We’re shaking up the Extracorporeal Life Support industry by creating innovative life support solutions focused on simplicity, performance and reliability.

At TandemLife You will Experience:

· An employee first environment
· A never ending supply of new learning experiences
· Coaching, mentoring, and opportunity for development
· Zero dull moments
· A rewarding journey in life-saving medical device technology

Current Job Opportunities

Clinical Research Associate

TandemLife is a nationally recognized medical device manufacturer headquartered 15 miles northeast of Pittsburgh. We are seeking a reliable, self-motivated, team player with a passion for contributing to helping save the lives of patients with cardiopulmonary life-threatening illnesses.
This newly created position supports the Clinical Affairs department management team with implementing and conducting clinical research projects. Responsible for on-site monitoring of clinical research studies both independently and as a co-monitor. Interface with study site research personnel, field clinical and sales staff, Clinical Research Organizations (CROs), vendors and other company representatives This position is corporate office-based.

Responsibilities and Duties

• Participate in the development and design of clinical study protocol, case report forms, informed consent forms and other study-related documentation for accurate and thorough data collection to secure successful clinical study outcomes
• Collaborate with the management team to identify, qualify, evaluate and select investigators and sites for clinical study participation.
• Perform on-site and remote monitoring visits independently and as a co-monitor according to the protocol, monitoring plan, SOPs, ICH-GCPs, Federal (CFR) regulations and local requirements at multiple investigational sites within specified timelines.
• Collect and file study and investigator/site regulatory documents in the Trial Master File (TMF); maintain the TMF; update study tracking tools.
• Interact with investigators, study coordinators and study personnel via telephone, email, written correspondence and on-site visits
• Serve as a resource to site investigators, coordinators, and other study personnel regarding protocols and study requirements, including performing ongoing protocol and regulatory training as needed.
• Submit completed monitoring visit reports within specified timelines to document visit findings. Promptly notify the management team of any issues related to the study, protocol, regulatory and/or GCP compliance.

Qualifications, Skills, and Abilities

• Bachelor’s degree or equivalent combination of education and experience in a health profession, life sciences, or biomedical field.
• 5 years of field clinical monitoring experience, including 3 in a regulated medical device studies, preferably cardiology/cardiac disease; multiple therapeutic areas considered.
• Thorough knowledge of ICH-GCP, applicable federal (CFR) regulations, and local regulatory requirements
• Current CRA certification (or working towards certification) preferred.
• Experience with electronic data capture and clinical trial management systems preferred.
• Proficient use of Microsoft Office Suite applications
• Experience with registries a plus
• Ability to travel up to 25% of time

Quality Control Inspector

TandemLife is a nationally recognized medical device manufacturer headquartered 15 miles northeast of Pittsburgh. We are seeking a reliable, self-motivated, team player with a passion for contributing to helping save the lives of patients with cardiopulmonary life-threatening illnesses.

The position requires the individual to perform quality assurance and quality control tasks, incoming, in process, and final inspections of medical devices and components in cleanroom and ESD environments.

Responsibilities and Duties

  • Perform quality control incoming, in process, and final inspections following written procedures for electro-mechanical medical devices utilizing test and measurement equipment
  • Perform detailed First Article inspections on new components
  • Complete and file quality records including process travelers, inspection reports, non-conforming material reports, supplier notifications, and reprocess orders
  • Review completed process travelers for accuracy and completeness
  • Perform sterile package seal testing using a tensile strength tester
  • Maintain the quality control inspection area in a neat and orderly manner
  • Assist in the development of quality control inspection processes, procedures, and documentation by utilizing the company’s engineering change order process
  • Assist with material review board meetings, present reports
  • Assist engineering as required to perform process and product validation testing

Qualifications and Skills

  • 5-8 years of experience with quality inspections and manufacturing processes
  • 3+ years of experience in quality or manufacturing for a medical device manufacturer
  • Familiarity with Microsoft Office, Geometric Dimensioning and Tolerancing, and the ability to read and interpret blueprints and schematics
  • Familiarity with FDA QSR and ISO 13485 requirements and IPC standards
  • Demonstrated competency in using general mechanical inspection tools including calipers, micrometers, and depth gauges
  • Ability to communicate with technical personnel and other employees
  • Attention to detail and exceptional organizational skills
  • Ability to work occasional overtime and weekends

Please submit all resumes to our HR Department:  humanresources2@tandemlife.com