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VnV Testing Technician

2 months ago

huntington, United States BiVACOR Full time

Verification and Validation Testing Technician

We are seeking a meticulous and technically proficient Verification and Validation Testing Technician to join our team. The successful candidate will be responsible for executing and monitoring the durability testing of medical devices, including the BiVACOR Total Artificial Heart, and performing additional testing such as Factory Acceptance Tests and equipment durability assessments.


Responsibilities

  • Test Setup and Preparation:

- Prepare and calibrate test loops and systems according to the Durability Test Protocol and other relevant test protocols.

- Ensure all necessary equipment, materials, and fluids are prepared, mixed, and maintained at the correct conditions.

- Connect and secure test articles to the test loop using the appropriate tools and methods.

  • Test Execution:

- Operate medical devices under various conditions (e.g., flow rates, pressures) as outlined in the protocols.

- Perform Factory Acceptance Tests (FAT), equipment durability tests, and other verification and validation procedures.

- Monitor and maintain the test environment, including temperature, salinity, and viscosity of the fluids used.

- Adjust equipment settings and parameters to ensure accurate and reliable test results.

- Handle biohazard materials according to safety protocols, including the decontamination of samples.

  • Data Collection and Analysis:

- Collect and record data from the data acquisition systems during all testing phases.

- Ensure all data is accurately documented in both electronic and manual forms and submitted for analysis.

- Analyze test data to identify any trends or anomalies and report findings to the engineering team.

  • Failure Investigation:

- Assist in identifying and investigating any test article malfunctions or failures, documenting the nature and cause of the failure.

- Collaborate with engineering teams to analyze test results and implement corrective measures.

  • Training and Compliance:

- Complete all necessary training as documented in the Training Verification Form.

- Adhere to all safety protocols, including handling biohazard materials and decontamination procedures.

- Maintain up-to-date vaccinations and certifications related to biohazard handling or be willing to train towards obtaining them.

- Adhere to all safety protocols and quality assurance procedures to ensure compliance with regulatory standards.


Requirements

  • Associate degree or equivalent technical training in a relevant field (e.g., Mechanical Engineering, Biomedical Engineering, Electronics).
  • Prior experience with laboratory testing, particularly in a medical device or related industry, is preferred.
  • Strong understanding of data acquisition systems, fluid dynamics, and mechanical testing procedures.
  • Experience with Factory Acceptance Testing, equipment durability testing, and handling biohazard materials is a plus.
  • Current vaccinations and biohazard handling certifications are preferred, or a willingness to obtain them.
  • Ability to troubleshoot technical issues and perform detailed inspections.
  • Excellent documentation and organizational skills.


BiVACOR offers a competitive compensation package to include 401k with above-average employer contributions, generous amount of time off, a choice of rich healthcare plans and an array of other benefits.


About the Company

BiVACOR is a clinical-stage medical device company pioneering the development of a long-term therapy for patients with biventricular heart failure. Under the expert direction of its founder and TAH inventor, Daniel Timms, PhD, and the guidance of two luminaries in cardiovascular surgery, William E. Cohn, MD, and O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an FDA-approved first-in-human Early Feasibility Study (EFS). Headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia, BiVACOR is committed to addressing the global unmet need of patients with end-stage heart failure awaiting transplant by providing the next generation of life-extending solutions. Our highly driven and performing team has complementary science and business minds to focus on “Replacing Hearts and Restoring Lives”.


Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us. To learn more about us go to www.bivacor.com.


BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email hr@bivacor.com.


BiVACOR does not accept profiles or resumes from recruiting firms without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by BiVACOR, implied or otherwise.