Electronics assembly/medical device contract manufacturing and System/Equipment Validation Engineering

New product development quality engineering support, test method development and validation, system/equipment validation engineering.

Procure alternate suppliers and manage supplier qualification and material validation.Manage manufacturing of a market released contraceptive product with a contract manufacturer outside of US.Responsible for product transfer of a new product to an international manufacturing facility. Managed production line development and set up production line to produce 100k devices/year. Manage product transfer, process development and process validation activities e.g. IQ, OQ, PQ, PPQ, Sterilization Validation, Packaging Validation, and introduction of alternate suppliers to eliminate single/sole source suppliers and performed Supplier Validation.

R&D and manufacturing responsibilities include: compression and injection mold design for heat cure elastomer (HCE) and liquid silicone rubber (LSR) materials, concept development of multilayer intubation and process development of first prototype, in parallel, forge alliance with a contract manufacturing company for mass production. Perform manufacturing assessment report, implement visual aids in manufacturing process instructions (MPI), create MPIs, create assembly drawings and routers, design tools/fixtures using Solidworks and fabricate fixtures with mill/lathe to help improve production efficiency and mitigate variability.

Managed and prepared all necessary activities needed for product design verification/validation tests. Managed test fixtures, test systems, and equipment replacement/re-ordering. Supervised drafting of tools/fixtures drawings. Set-up logistics for receiving and distribution of test units to on-sites and off-sites test labs. Directed and coordinated clinical study tests for Design Verification and Human Clinical lot release.Performed data collection, data verification, data analysis and data rendering.Performed FIR (Failure Investigation Reports) and corrective and preventive action CAPA on failed units. Directed and coordinated tests equipment IQ/OQ.Developed test methods for; balloon wall thickness, balloon OD, balloon uniformity, balloon compliance and balloon working length.Designed test fixtures and facilitated fabrication of the test fixtures with machinists.Developed test methods and performed test method validation report.Developed Rx Catheter from concept to assembling prototype and finished product.Performed material characterization and material selection used for RX catheter.Performed design characterization and design verification.Performed process feasibility studies, process development, process characterization, process confirmation, performance qualification and process validation. Proficient in writing engineering test protocols, test reports and test method instructions and manufacturing instructions.

Directed and coordinated manufacturing aids categorization and re-classification.Performed production equipment IQ, OQ, and PQ. Re-engineered manufacturing aids/equipment used to support manufacturing. Performed qualification and validation of manufacturing aids.

Developed a custom chemical-solution mix for etching and electro-polishing nickel titanium stent.Developed a post process for removing oxide on nickel titanium stent post laser cut process. Managed all manufacturing activities relating to production of nickel titanium stent. Transferred product from the R&D to manufacturing.Supported manufacturing on line support, associates training and certification.Managed product transfer from R&D to an oversea manufacturing site.