Postmarket Surveillance Intern

The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra's solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life.

This position is accountable for supporting postmarket surveillance activities associated with the Kestra Wearable Cardioverter Defibrillator (WCD), a marketed medical device prescribed to patients at risk for sudden cardiac arrest. Principally, this involves initial processing of patient complaints regarding WCD system problems that have been relayed by Kestra helpline support personnel. The intern will interface weekly with Kestra quality system personnel, supplier quality engineering, and design engineering personnel in review of product complaint assessments and disposition.

The intern is required to train to Kestra's industry-compliant quality system, as the work will include creating records that meet US Food and Drug Administration (FDA) regulations. At the conclusion of the internship, the participant will have gained considerable insight and experience in complying with a regulated industry, i.e., the medical device industry.

This is a part-time summer internship position (less than 30 hours a week), working with the Complaints Coordinator team at Kestra.

Essential Duties

• Participate in the receipt, processing, monitoring, and reporting of product defect complaints.
• Daily, weekly and monthly review of reported complaints and/or product returns for trending and identification of potential regulatory reporting and corrective / preventive actions.
• Document product complaints using several databases for sourcing, reporting, trending and analyzing device defects, while ensuring the complaint process is completed in accordance with corporate procedures.
• Interface with Customer Care team members and/or Kestra field personnel to gather additional information required for complaint initiation/investigations, including the retrieval of suspect equipment for evaluation.
• Interface with contract manufacturer/distributor personnel regarding status of customer-returned products for failure investigation and follow-up reporting.
• Partner with Customer Care department team members to accurately record and trend product problems and provide feedback to Customer Care and/or Kestra field personnel, as needed.
• Perform database queries to provide and/or confirm complaint data on reported product complaints.
• Ensure compliance with Kestra Quality System, the U.S. FDA Code of Federal Regulations, ISO 13485, ISO 14971 and other International Quality Standards as appropriate.
• Project Presentation: Present internship project results and findings to the Quality and Regulatory Affairs team and Kestra executive leadership at the conclusion of the internship
  
  
  

COMPETENCIES

• Integrity: Commitment, accountability, and dedication to the highest ethical and legal standards.
• Collaboration/Teamwork: Interface with Kestra personnel regardless of geography, position, or experience.
• Action/Results: High energy, observant to detail, timely execution.
• Innovation: Generation of new ideas and/or improvements from original thinking.
• Customer Focus: Quality of work, services, and experience always present of mind.
• Emotional Intelligence: Recognizes, understands, manages one's own emotions and can influence others.
  
  
  

Requirements

QUALIFICATIONS

Education/Experience Required:

• 1 years in an undergraduate degree program with an intended focus on healthcare, manufacturing, or engineering fields
• Strong written and oral communication skills
  
  
  

WORK ENVIRONMENT

• Indoor open office environment
• Minimal noise volume typical to an office environment
• Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment, post-offer.
  
  
  

INTERNSHIP ELIGIBILITY

• Must be enrolled in an accredited college/university taking at least one class in the semester/quarter (spring/fall) prior to participation in the internship program OR must have graduated from a college/university within the past 6 months
• Must not have completed one year of continual employment with Kestra Medical Technologies
• Must be at least 18 years of age
• Must possess unrestricted work authorization
• Must provide own transportation to/from work
• Must successfully complete and pass a criminal and employment background screening that meets the allowable FDA requirements and is in accordance with EEOC rules and regulations
• Must successfully pass a pre-internship drug screen
  
  
  

PHYSICAL DEMANDS

• Repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
• Frequent stationary position, often sitting for prolonged periods of time
• Frequent computer use
• Occasional lifting up to 20 pounds
  
  
  

Other Duties

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

PROGRAM LENGTH

The approximate dates of this summer internship are May 2025 through Sep 2025 with the understanding that not all higher education academic calendars will fit the entire range. Interns must be available to work for the duration of the internship time period agreed upon at the time of interview.

Benefits

Pay equity is an important part of Kestra's Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided. If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.

Pay: $25.00/hour

Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.

We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S.