Pedro De La Serna Email & Phone Number

Irvine, Ca, Us

Research and recommend CNC manufacturing equipment (Capital equipment in excess of $1MM)Design manufacturing processes using integrated part handling, high speed machining , and decreased cycle times.Design tooling and work holding for increased throughput and part quality.Establish material process flow and facility configuration.Support external suppliers for improved part quality and reduced cost.Efforts have resulted in >40% reduction in cycle times.Excellent at cross functional team building to achieve results.Versed in FMEA, IQ, OQ, PQ, Control Charts, Root Cause Investigations.Experienced with Creo 3D CAD and GD&T

Provide expertise in areas of manufacturing, outsourcing, and supplier quality improvements.Consult on machining equipment, tooling, fixturing for improved quality and reduced cycle times.Consult in the design and development of medical devices.Audit suppliers for compliance to customer specifications. Visit and consult with international and local suppliers to improve manufacturing methods for throughput and quality improvements.Author Inspection Plans, FMEAs, Installation Qualifications, Operational Qualifications.

Foster City, California, Us

Nasal delivery of therapeutic gas (Serenz Nasal Relief) – Monthly disposable combination device• Managed cross functional team that culminated in commercial launch of product.• Fundamental contributor from inception, through design control, to commercialization.• Primary contributor in the design of both clinical and commercial versions of the product.• Designed flow control mechanism capable of precisely regulating the flow of gas from a high-pressure vessel. Refined and transferred design from high value components for the clinical supply, to high volume low cost contract manufacturing for commercial launch.• Managed external support groups- engineering, manufacturing, molding, ISO 9001/13485/FDA certified suppliers.• Patents pending and issued.Electromechanical diagnostic instrument (CoSense ETCO Monitor)• Fundamental contributor from inception, through design control, to commercialization.• Created project plans, schedules and budgets for device development.• Managed team of engineers in the design, development, and validation of the CoSense ETCO monitor. Worked with external suppliers to validate new electrochemical sensor technologies. Developed new methods and equations that improved device accuracy and reliability. Engineered microfluidics for capturing and measuring breath samples which extended system accuracy and range.• Authored design validation protocols, acceptance criteria, and product performance specifications.• Designed validation plans for manufacturing line (IQ/OQ) and generated test reports.• Patents pending and issued.

ASCENT DESIGN AND MANUFACTURING, INC., SANTA CLARA, CA.• Consulted with pharmaceutical companies in the areas of product research, product design, and manufacturing methods.Product design• Collaborated in determining the feasibility of a disposable needle-free ocular injector (past the sclera into the vitreous body). Managed external consulting firms in CFD analysis and materials development. Engineered the product design and provided prototypes for in-vivo testing. • Designed improved Implanter for the subcutaneous insertion of implantable drug delivery device (osmotic powered extended release implant).Equipment• Consulted in the design of high volume manufacturing equipment for the commercial manufacture of an implantable drug delivery device (controlled release implant). Sourced equipment manufacturers and developed timelines, specifications, and budgetary requirements.• Contributed to the authoring of IQ and OQ procedures to validate the manufacturing equipment.• Designed test equipment for reliability and lot release testing of iontophoretic transdermal patches.

SPACE SYSTEMS/LORAL, PALO ALTO, CA.• Led cross functional team to ensure on time delivery of multimillion-dollar satellite systems. Project managed all phases of the build cycle- scheduled and interacted with cross functional support groups (thermal, antenna, shock, quality control, and engineering) under severe time constraints and scheduling challenges.• Generated build instructions for mission critical flight hardware. Developed manufacturing and test procedures to ensure compliance to specifications.• Championed the development and implementation of 3D Printing for Flight Ready Titanium Hardware.• Managed team of technicians to maintain project schedule and build quality.• Led Lean Teams for cost reduction in manufacturing areas.• Performed vendor surveys and reviewed their qualifications for the manufacture of flight hardware.

ALZA CORPORATION (J&J), MOUNTAIN VIEW, CA.Biomedical Engineering Group• Researched market landscape for the development of new products and IP. Created invention records and proof of concepts for different drug delivery platforms. • Principal design engineer for a subcutaneous needle-free injector. Took design from conceptual to proof of concept in-vivo testing. • Collaborated in gastric retention designs using erodible polymers which could be used for drug delivery, or combined with electronics for vagal nerve stimulation. Took design from proof of concept to in-vivo testing.• Patents pending and issuedImplant Group• Primary inventor of an autoinjector for the subcutaneous and intramuscular delivery of highly viscous depot gels. Dual stage pneumatic injector with a self-retracting disposable syringe cartridge. Developed entire system for ease of use and marketability. Developed design for ease of manufacturing and gamma sterilization.• Designed subcutaneous osmotic implant with improved reliability and steady state delivery profiles.• Patents pending and issuedDevelopmental Engineering Group• Staff engineer to support manufacturing and engineering teams. Diagnosed and corrected design problems with installed aseptic manufacturing equipment. Redesigned product pick and place handling equipment to eliminate errors in initial design and manufacturing down time. Improved device filling station to better handle viscous gels.

MEADOWS MANUFACTURING, SUNNYVALE CA.• Managed Machine Shop and was responsible for sourcing CNC Equipment. Grew shop from one CNC to twenty units over a period of three years. Managed group of engineers in the development of automated manufacturing equipment for the medical and semiconductor industries.• Developed novel formulation method and manufacturing equipment for emerging drug delivery platform (implanter for formulation in PEG suspension). Manufacturing equipment included motion control, user interface, and in-process inspection. Managed all phases of program from proof of concept to commercial launch. Worked with cross functional teams to develop IQ and OQ plans.• Redesigned disposable implanter for ease of manufacture and reliability.

Bachelor'S Of Science, Quality Assurance

Iso 9001, Iso 13485 Medical Product Development Certificate

School Of Engineering- Manufacturing Systems