Michael Martinez

Background

About Michael Martinez

SUMMARY Dedicated Manufacturing/Production team member with 16 years of experience in regulated environments involving medical devices and pharmaceuticals. Demonstrated ability to perform and document technical functions relating to testing, layout, quality control, fabrication, modification and assembly of mechanical and electrical equipment and components. SKILLS • Hands on experience with all types of medical assembly processes: automated filling machine, crimping machine, balloon bumping, thermal bonding, pleating & folding machine, sealing machine, laser micrometer, instron machine, hot box, multivac sealer, fuji heat sealer, sonicators, forming machine, automated coating machine, automated assembly machine, fusing and leak testing. • Detail oriented with excellent compliance with Quality and Regulatory policies. • Proficient in GMP, SOP, DHR and GDP practices. • Production of medical device lots for clinical and FDA submission documentation. • Effective partner with R&D teams for process design and optimization. • Start-up Experience: Member of early, highly motivated staff for Conor Medsystems (purchased by J&J for $1.4B). • Selected as subject matter expert to transfer technical ‘know-how’ (high-speed piezo jet drug delivery system for coronary stents) to commercial operations in Ireland (5 visits). • Active member of R&D support team to: o Execute DOE – (executed several Design of Experiments to determine relative impact of temperature, humidity and other factors for piezo jet depositions of drugs). o Troubleshoot system anomalies -(production process automation for drug filling of coronary stents, catheter assembly and test).