David Ormonde Email & Phone Number

Saint Paul, Mn, Us

St Paul, Minnesota, United States

Authorized medical device reviewer under MDD & MDR for MDN1101_1 (Heart Implants), MDN1101_1 (Vascular Prosthesis), and MDN1203 (Catheters, Introducers, Guidewires). Carried out assessment of sterilization, packaging, biocompatibility , and clinical modules for Class II technical files. Conducted Class III medical device Conformity Assessments under both MDD and MDR for a wide variety of clients ranging from start-ups to Fortune 100 companies. Planned and managed Certifications across manufacturers and product portfolios.Served as Project/Client Manager for an extensive device and client portfolio.Onboarded multiple new team members, including training in project management, device assessments, and internal processes. Received the 2020 TUV SUD America “Extra Mile” divisional award for training and mentoring new team members during the critical MDD/MDR transitional period.Certified Lead Auditor for ISO 13485 (Oct. 2020) and ISO 9001 (Mar. 2020).

Roseville, Mn

Saint Paul

Minnetonka, Mn

Designed and carried out a variety of custom testing solutions for medical devices in an ISO 17025 and A2LA accredited laboratory. Worked extensively with Bose/Enduratec ELF and SGT systems, as well as Instron pull & fatigue testers. Experienced in test protocol documentation, error analysis and root cause, and data reporting and documentation. http://www.devicetesting.comI was instrumental in designing and carrying out research on the impact of various types of dynamic fatigue on the release of Nickel Ions from Nitinol material. A webinar giving an overview of the project is linked below.Co-Author, Nagaraja, S., Chandrasekar, V., Ormonde, D., Lipschultz, K., Chao, C., & Vilendrer, K. (2017). Effects of Fatigue Testing on Nickel Release in Nitinol Stents. Shape Memories & Superelastic Technologies Conference. (Presented May 19th, 2017, San Diego, CA.)

Saint Paul, Mn

• Tested and offered feedback on the design of trans-catheter aortic valve implants.• Designed and implemented test methods and devices throughout the R&D process.• Coordinated tissue processing, personnel, and requirements across several operational groups.• Attended several animal study implantations and clean room procedures.Throughout my internship I worked on the Portico Transcatheter Aortic Valve Implant:https://www.youtube.com/watch?v=idxDEP4qOdI

Minneapolis Mn

● Contributed to design and building of the largest free-standing plastic structure in the world.● Developed and refined hermetic sealing process for module manifolds.● Maintained workplace safety standards while working with corrosive and carcinogenic materials.● Led a team of 3-8 undergraduates in applying seals and in a comprehensive quality-assessment process.

Minneapolis Twin-Cities Campus

● Act as a visible uniformed presence on campus patrolling independently, checking building and grounds security, and controlling access to campus facilities.● Provide personal escorts to students, faculty, and staff.● Coordinate with campus safety officials, police officers, and medical personnel during incidents.

Bs, Mechanical Engineering

Activities and Societies: Kappa Eta Kappa Professional Engineering Fraternity, University of Minnesota Student Senate- Committee.

Highschool Diploma