David G.

Experience

• NPI Product Engineer Gener8 · Full-time Jul 2023 – Sep 2025 2 yrs 2 mos Costa Rica First NPI engineer for the Costa Rica site. Promoted to NPI Engineer after only 12 months due to per-
  formance, exceptional aptitude for leading transfer projects, and problem-solving.
  + Became the NPI manager’s backup and a go-to expert given my strong technical knowledge.
  + Have led as SME 5 transfers of medical/commercial equipment and other minor assemblies, planning
  and executing the proper validation, ensuring ISO 13485 compliance and on-time delivery. Each project
  was valued at an average of $4M annually in profit.
  + Made effective 1000+ engineering change orders, including self-made documentation such as, but not
  limited to, MVPs, Validation protocols and reports (IQ, OQ, PQ), Drawings, Work Instructions, Risk
  Assessments, TMVs, pFMEAs, FAIs, SATs, FATs, Forms, Procedures, Flow Diagrams, and Product
  Trees.
  + Co-created the MVP template so that the transfer plan was well established throughout all areas (Supply
  Chain, QA, Engineering, and Manufacturing).
  + Great knowledge in assessing new designs for DFM and DFA. This assessment included making sure
  components have more than one manufacturer and comply with the best practices and tolerances
  according to the manufacturing method (Injection molding, casting, machining, 3D printing, sheet
  metal).
  + Experience in handling and leading NCRs and CAPAs, ensuring compliance with regulatory requirements
  and internal procedures.
  + Have created process improvement fixtures, saving on average $2K annually in labor per each and
  improving EHS.
  + Served as virtual audit lead for ISO 9001/13485 BSI certification.
  + Demonstrated my proactivity by automating processes with self-taught Python programming.
• Transfer Engineer Gener8 · Full-time Apr 2022 – Jul 2023 1 yrs 3 mos Costa Rica Startup experience opening the Costa Rica site for Gener8, the first site outside of the USA. 4-month
  training experience in Sillicon Valley, California at Gener8’s main site. Responsible for leading the transfer
  of projects with the corresponding validation. Given my experience in the quality department, I was the
  main backup of the QA manage
• QA ENGINEER Biomerics · Full-time Apr 2020 – Apr 2022 2 yrs Costa Rica Responsible for creating PPAP documentation (Control Plan, Flow Diagram, pFMEA, DMR) for 6
  upcoming medical device projects and looking over 4 existing ones. These projects included various models
  of catheters + introducers, class 3 implantables, medication mixing and delivery devices, and devices
  to treat sinusitis. Personnel management (2 quality inspectors with direct reporting), hiring, overseeing
  a class 8 cleanroom, being the DHR representative, being the QA point of contact for the clients, and
  internal auditing were additional functions assigned to my position.