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.

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.

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.
• Managed external support groups- engineering, manufacturing, molding, ISO 9001/13485/FDA certified suppliers.

• 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.
• 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.
• Contributed to the authoring of IQ and OQ procedures to validate the manufacturing equipment.

• 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.
• 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.

• 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.

• 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.
• 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.
• 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