Getinge - Atrium Medical Vascular Grafts

December 2023 - Present

Duties -

• I am currently a member of the Vascular Grafts Product Engineering group at Getinge where I am completing sustaining work for the Advanta VXT and Flixene Vascular Grafts product lines.

• I developed, validated and rationalized numerous test methods for design verification to prove clinical compliance.

• Fully staged an organized test flow, completed personnel training and used sample preparation strategies for a full stage design verification study (Handling and Distribution/Aging) to reduce cost and coordinate timings with Program Management.

• Completed CAPA investigations and action planning phases to determine root cause of complaint occurrences.

  • Led evaluations of patient impact from complaints and out of specification test results.

• Assessed and documented product conformance to common Medical Device ASTM/ISO/ANSI/AAMI standards.

• Updated documentation within the Agile PLM software including risk documentation and production procedures. 

Challenges and Skills Gained -

• Gained valuable experience within the Risk Management process, actively working with and participating in courses geared towards ISO 14971.

  • Experienced large amounts of risk documentation which I was previously unfamiliar with and became comfortable within DFMECA's, Product Requirements and Standard Conformance Reviews.

• Was able to explore the sustaining engineering role which was a new aspect of the product lifecycle that I had not been heavily involved with.