Establish manufacturing line for first commercial build of catheter based tissue sampler.Equipment design & development.Process validation using DOE & statistical analysis.Creating manufacturing instructions.

Support Quality Group with Verification & Validation documentation & qualification activities for medical device product lines

Project Manager for transfer into manufacturing of a new direct LDL in-vitro rapid diagnostic product.Equipment validation for fully automatic manufacturing line.Project manager for automated coating of enzymatic reagents on polysulfone membrane substrates.Generate validation & verification documentation for processes & equipment – IQ, OQ, PQ’s, validation protocols & reports, engineering studies.Establish SPC for emerging product lines.Assist in relocation of manufacturing site to Southern California.

Participated in outsourcing projects working closely with suppliersDesign develop and implement assembly and test fixturesDevelop manufacturing processesResolve daily production and assembly issues.Implementation of six sigma manufacturing systems.

Process Engineer for implant modification in response to customer complaints.Project Manager for new catheter Introducer. Design of device, vendor selection, regulatory submission.Process Engineer for redesign of implant release mechanism. Initial brainstorming, prototype fabrication, packaging design, process validations.Project Manager for interactive surgeon training module. Customer feedback, vendor evaluations.

Project Manager for major cost improvement program involving vendor interfacing and product & process validation.Manufacturing Engineer for three new product development programs requiring generation of documentation and process / product validation.Responsible for sustained engineering on Surgical Probe line, cost improvement and design of line equipment.

Design, fabricate, validate and transfer into manufacturing two semi-automatic cell culture flask process workstations and one fully automated polystyrene felted pad process station.Development work on antibody coating of polystyrene beads and flasks. This required design and fabrication of a pilot plant for coating and dispensing processes.Design & validation of scaled up manufacturing equipment for cell capture & subsequent culture.Assist in the validation of manufacturing equipment and processes for manufacturing & cell processing facility.DOE & statistical analysis to establish process capability, robustness & controls.