Engineer with MS degree and 5+ years of experience the medical device industry (Class I, II and III). Ability to work with diverse teams, multitask and work productively under tight timelines. Possessing outstanding leadership, organizational, analytical and communication skills. Proactive, enthusiastic team player with a strong desire to produce quality results and also capable of working independently and collaboratively.
TOP SKILLS
Analysis: matlab, mathematica, minitab.Engineering: authoring & executing validation protocols (iq, oq, pq), implementing gxp (gmp, gdp, glp), capa, root cause analysis (rca), closing nonconformance reports (ncr) & nonconformance material reports (ncmr), control plans, iso 13485, iso 14971, qsr 21 cfr part 820, iso 11607, test method validation (tmv), gage reproducibility & repeatability studies (gage r&r), fault tree analysis, 5-why analysis, control process parameters (cpp), statistical process controls (spc), minitab, geometric dimensioning & tolerance (gd&t), six-sigma, lean & kaizen, standard operating procedures (sops), design history files (dhf), design of experiments (doe), dfmea, pfmea, fmea, scar.Computer skills: ms-office, sharepoint, etq reliance, enovia (matrix), wind-chill, telelogic, tipqa, track wise and client owned plm/pdms.Design: auto cad, solid works.
